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Clinical Trial Results:
Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients

Summary
EudraCT number	2016-001879-73
Trial protocol	Outside EU/EEA
Global end of trial date	01 May 2006

Results information
Results version number	v2(current)
This version publication date	07 Dec 2016
First version publication date	31 Jul 2016
Other versions	v1
Version creation reason	New data added to full data set Additional study-specific data added to baseline measures

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

E3810-A001-202

ISRCTN number

US NCT number

NCT00132496

WHO universal trial number (UTN)

Sponsor organisation name

Eisai Medical Research Inc.

Sponsor organisation address

100 Tice Boulevard, Woodcliff Lake, United States, 07677

Public contact

Eisai Medical Information, Eisai Medical Research Inc., 1 8882742378, esi_medinfo@eisai.com

Scientific contact

Eisai Medical Information, Eisai Medical Research Inc., 1 8882742378, esi_medinfo@eisai.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-000055-PIP01-07

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

01 May 2006

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

01 May 2006

Was the trial ended prematurely?

Main objective of the trial

To collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16 years.

Protection of trial subjects

This study was conducted in accordance with standard operating procedures (SOPs) of the sponsor (or designee), which are designed to ensure adherence to Good Clinical Practice (GCP) guidelines as required by the following: - Principles of the World Medical Association Declaration of Helsinki (World Medical Association, 2008) - International Council on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products, International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Title 21 of the United States (US) Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and Institutional Review Board (IRB) regulations and applicable sections of US 21 CFR Part 312 - European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country. All suspected unexpected serious adverse reactions were reported, as required, to the Competent Authorities of all involved EU member states. - Article 14, Paragraph 3, and Article 80-2 of the Pharmaceutical Affairs Law (Law No. 145, 1960) for studies conducted in Japan, in addition to Japan’s GCP Subject Information and Informed Consent.

Background therapy

Evidence for comparator

Actual start date of recruitment

18 Aug 2005

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 111

Worldwide total number of subjects

111

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

111

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 119 participants were screened and of these, 111 were enrolled into the study, 54 participants received 10 mg rabeprazole and 57 participants received 20 mg rabeprazole from Week 1 through Week 8.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

10 mg Rabeprazole sodium

Arm description

Participants had a screening evaluation within 2 weeks prior to starting study drug administration. Participants received 10 mg rabeprazole once daily at the same time each day for 8 weeks, with a follow-up visit at Week 10.

Arm type

Experimental

Investigational medicinal product name

Rabeprazole sodium

Investigational medicinal product code

E3810

Other name

Pharmaceutical forms

Coated tablet

Routes of administration

Oral use

Dosage and administration details

Rabeprazole sodium was administered orally, once per day for up to 8 weeks.

20 mg Rabeprazole sodium

Arm description

Participants had a screening evaluation within 2 weeks prior to starting study drug administration. Participants received 20 mg rabeprazole once daily at the same time each day for 8 weeks, with a follow-up visit at Week 10.

Arm type

Experimental

Investigational medicinal product name

Rabeprazole sodium

Investigational medicinal product code

E3810

Other name

AcipHex

Pharmaceutical forms

Coated tablet

Routes of administration

Oral use

Dosage and administration details

Rabeprazole sodium was administered orally, once per day for up to 8 weeks.

Number of subjects in period 1	10 mg Rabeprazole sodium	20 mg Rabeprazole sodium
Started	54	57
Completed	52	55
Not completed	2	2
Physician decision	1	-
Consent withdrawn by subject	1	2

Baseline characteristics

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Reporting group title

10 mg Rabeprazole sodium

Reporting group description

Reporting group title

20 mg Rabeprazole sodium

Reporting group description

Reporting group values	10 mg Rabeprazole sodium	20 mg Rabeprazole sodium	Total
Number of subjects	54	57	111
Age categorical
Units: Subjects
In utero			0
Preterm newborn infants (gestational age < 37 wks)			0
Newborns (0-27 days)			0
Infants and toddlers (28 days-23 months)			0
Children (2-11 years)			0
Adolescents (12-17 years)			0
Adults (18-64 years)			0
From 65-84 years			0
85 years and over			0
Age continuous
Units: years
arithmetic mean (standard deviation)	14.2 ± 1.29	14.1 ± 1.49	-
Gender categorical
Units: Subjects
Female	27	26	53
Male	27	31	58
Race/Ethnicity
Units: Subjects
Asian	0	0	0
Black or African American	4	1	5
White	47	53	100
Hispanic	1	2	3
Other	2	1	3

End points

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Reporting group title

10 mg Rabeprazole sodium

Reporting group description

Reporting group title

20 mg Rabeprazole sodium

Reporting group description

Primary: Summary of Adverse Events (AEs)

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End point title

Summary of Adverse Events (AEs) ^[1]

End point description

Safety variables included AEs, serious AEs, laboratory evaluations (hematology, clinical chemistry, and urinalysis), vital signs (blood pressure and pulse rate, respiration rate, oral temperature), and physical examinations. The safety of rabeprazole sodium was evaluated based on incidence of treatment-emergent adverse events (TEAEs), critical changes in clinically relevant laboratory values, and physical examinations. AEs were assessed weekly (during study visits and by phone) and laboratory tests were performed at Screening, Baseline and at the end of active study drug treatment (Week 8 or when the participant discontinued the study). The safety population was used and included all participants who received at least one dose of study treatment.

End point type

Primary

End point timeframe

Screening Visit up to Week 12

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical analysis was not performed.

End point values	10 mg Rabeprazole sodium	20 mg Rabeprazole sodium
Number of subjects analysed	54	57
Units: Participants
number (not applicable)
TEAEs	31	35
Treatment-related TEAEs	8	8
Serious AEs	0	1
Withdrawal due to TEAEs	0	0

No statistical analyses for this end point

Secondary: Change in Frequency of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8 at Nighttime

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End point title

Change in Frequency of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8 at Nighttime

End point description

Change in frequency of GERD symptoms was computed as frequency of a symptom collected during a given week visit minus frequency count recorded at baseline. Five primary GERD symptoms were assessed: heartburn, regurgitation, nausea, vomiting, and epigastric pain. The participant was also able to choose two other symptoms of concern from a list of twenty possible symptoms. The participant noted in their diary the number of episodes of each symptom and time of occurrence (daytime and/or nighttime). A negative value indicates a decrease in mean frequency of a symptom. The Intent-to-treat (ITT) population was used and included all participants in the Safety population who also had at least one post-baseline assessment.

End point type

Secondary

End point timeframe

Baseline (including Screening values) to Week 8 (Wk 8) and Baseline (including Screening values) to Week 10 (Wk 10)

End point values	10 mg Rabeprazole sodium	20 mg Rabeprazole sodium
Number of subjects analysed	54	57
Units: Change in frequency
arithmetic mean (standard deviation)
Heartburn Week 8 - Baseline (n = 48, 51)	-0.21 ± 0.503	-0.48 ± 0.727
Heartburn Week 10 - Baseline (n = 48, 52)	-0.18 ± 0.462	-0.4 ± 0.684
Heartburn Week 10 - Week 8 (n = 51, 54)	0.03 ± 0.219	0.07 ± 0.196
Regurgitation Week 8 - Baseline (n = 48, 51)	-0.1 ± 0.328	-0.21 ± 0.612
Regurgitation Week 10 - Baseline (n = 48, 52)	-0.13 ± 0.34	-0.15 ± 0.522
Regurgitation Week 10 - Week (n = 51, 54)	-0.02 ± 0.126	0.05 ± 0.266
Nausea Week 8 - Baseline (n = 48, 51)	-0.19 ± 0.686	-0.24 ± 0.446
Nausea Week 10 - Baseline (n = 48, 52)	-0.19 ± 0.68	-0.17 ± 0.482
Nausea Week 10 - Week 8 (n = 51, 54)	-0.02 ± 0.195	0.04 ± 0.161
Vomiting Week 8 - Baseline (n = 48, 51)	-0.07 ± 0.358	-0.04 ± 0.283
Vomiting Week 10 - Baseline (n = 48, 52)	-0.07 ± 0.351	-0.01 ± 0.191
Vomiting Week 10 - Week 8 (n = 51, 54)	0.01 ± 0.028	0.03 ± 0.121
Epigastric Pain Week 8 - Baseline (n = 48, 51)	-0.12 ± 0.62	-0.29 ± 0.523
Epigastric Pain Week 10 - Baseline (n = 48, 52)	-0.17 ± 0.417	-0.22 ± 0.473
Epigastric Pain Week 10 - Week 8 (n = 51, 54)	-0.07 ± 0.485	0.06 ± 0.226
Other Week 8 - Baseline (n = 38, 45)	-0.21 ± 0.921	-0.76 ± 1.069
Other Week 10 - Baseline (n = 38, 45)	-0.08 ± 1.479	-0.57 ± 1.055
Other Week 10 - Week 8 (n = 43, 49)	0.1 ± 0.739	0.18 ± 0.408

Heartburn Frequency at Night Wk 8 - Baseline

Statistical analysis description

Testing of hypotheses on efficacy parameters was conducted for exploratory purposes and P-values were calculated without multiplicity adjustment for multiple endpoints. Appropriate parametric and/or nonparametric statistics were applied. All tests were two-sided. A P-value of <0.05 indicated a significant difference between the two treatment groups in the parameter of interest. Analysis of covariance (ANCOVA) was employed.

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[2]

P-value

= 0.833 ^[3]

Method

ANCOVA

Confidence interval

Notes
[2] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[3] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Heartburn Frequency at Night Wk 10 - Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[4]

P-value

= 0.737 ^[5]

Method

ANCOVA

Confidence interval

Notes
[4] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[5] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Heartburn Frequency at Night Wk 10 – Wk 8

Statistical analysis description

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[6]

P-value

= 0.196 ^[7]

Method

ANCOVA

Confidence interval

Notes
[6] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[7] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Regurgitation Frequency at Night Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[8]

P-value

= 0.914 ^[9]

Method

ANCOVA

Confidence interval

Notes
[8] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[9] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Regurgitation Frequency at Night Wk 10 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[10]

P-value

= 0.271 ^[11]

Method

ANCOVA

Confidence interval

Notes
[10] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[11] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Regurgitation Frequency at Night Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[12]

P-value

= 0.072 ^[13]

Method

ANCOVA

Confidence interval

Notes
[12] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[13] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Nausea Frequency at Night Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[14]

P-value

= 0.671 ^[15]

Method

ANCOVA

Confidence interval

Notes
[14] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[15] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Nausea Frequency at Night Wk 10 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[16]

P-value

= 0.147 ^[17]

Method

ANCOVA

Confidence interval

Notes
[16] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[17] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Nausea Frequency at Night Wk 10 – Wk 8

Statistical analysis description

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[18]

P-value

= 0.139 ^[19]

Method

ANCOVA

Confidence interval

Notes
[18] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[19] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vomiting Frequency at Night Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[20]

P-value

= 0.821 ^[21]

Method

ANCOVA

Confidence interval

Notes
[20] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[21] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vomiting Frequency at Night Wk 10 – Baseline

Statistical analysis description

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[22]

P-value

= 0.047 ^[23]

Method

ANCOVA

Confidence interval

Notes
[22] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[23] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vomiting Frequency at Night Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[24]

P-value

= 0.105 ^[25]

Method

ANCOVA

Confidence interval

Notes
[24] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[25] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Epigastric Pain Frequency at Night Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[26]

P-value

= 0.304 ^[27]

Method

ANCOVA

Confidence interval

Notes
[26] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[27] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Epigastric Pain Frequency at Night Wk 10–Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[28]

P-value

= 0.795 ^[29]

Method

ANCOVA

Confidence interval

Notes
[28] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[29] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Epigastric Pain Frequency at Night Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[30]

P-value

= 0.098 ^[31]

Method

ANCOVA

Confidence interval

Notes
[30] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[31] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Other Frequency at Night Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[32]

P-value

= 0.026 ^[33]

Method

ANCOVA

Confidence interval

Notes
[32] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[33] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Other Frequency at Night Wk 10 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[34]

P-value

= 0.125 ^[35]

Method

ANCOVA

Confidence interval

Notes
[34] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[35] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Other Frequency at Night Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[36]

P-value

= 0.117 ^[37]

Method

ANCOVA

Confidence interval

Notes
[36] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[37] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Secondary: Change in Frequency of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8 at Daytime

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End point title

Change in Frequency of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8 at Daytime

End point description

End point type

Secondary

End point timeframe

Baseline (including Screening values) to Week 8 and Baseline (including Screening values) to Week 10

End point values	10 mg Rabeprazole sodium	20 mg Rabeprazole sodium
Number of subjects analysed	54	57
Units: Change in frequency
arithmetic mean (standard deviation)
Heartburn Week 8 – Baseline (n = 48, 51)	-0.54 ± 1.097	-0.88 ± 1.147
Heartburn Week 10 – Baseline (n = 48, 52)	-0.42 ± 0.953	-0.46 ± 1.174
Heartburn Week 10 – Week 8 (n = 51, 54)	0.11 ± 0.492	0.42 ± 1.253
Regurgitation Week 8 – Baseline (n = 48, 51)	-0.3 ± 0.961	-0.42 ± 1.159
Regurgitation Week 10 – Baseline (n = 48, 52)	-0.21 ± 0.939	-0.2 ± 0.772
Regurgitation Week 10 – Week 8 (n = 51, 54)	0.09 ± 0.49	0.21 ± 0.679
Nausea Week 8 – Baseline (n = 48, 51)	-0.55 ± 0.978	-0.41 ± 0.697
Nausea Week 10 – Baseline (n = 48, 52)	-0.45 ± 0.963	-0.3 ± 0.802
Nausea Week 10 – Week 8 (n = 51, 54)	0.07 ± 0.459	0.09 ± 0.454
Vomiting Week 8 – Baseline (n = 48, 51)	-0.09 ± 0.458	-0.04 ± 0.246
Vomiting Week 10 – Baseline (n = 48, 52)	-0.09 ± 0.458	0.01 ± 0.326
Vomiting Week 10 – Week 8 (n = 51, 54)	-0.01 ± 0.069	0.05 ± 0.194
Epigastric Pain Week 8 – Baseline (n = 48, 51)	-0.5 ± 0.874	-0.54 ± 0.811
Epigastric Pain Week 10 – Baseline (n = 48, 52)	-0.35 ± 0.957	-0.46 ± 0.8
Epigastric Pain Week 10 – Week 8 (n = 51, 54)	0.12 ± 0.785	0.06 ± 0.359
Other Week 8 – Baseline (n = 38, 45)	-1.73 ± 2.136	-2.51 ± 9.085
Other Week 10 – Baseline (n = 38, 45)	-1.14 ± 2.661	-2.12 ± 8.819
Other Week 10 – Week 8 (n = 43, 49)	0.5 ± 2.777	0.37 ± 0.803

Heartburn Frequency at Daytime Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[38]

P-value

= 0.282 ^[39]

Method

ANCOVA

Confidence interval

Notes
[38] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[39] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Heartburn Frequency at Daytime Wk 10 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[40]

P-value

= 0.817 ^[41]

Method

ANCOVA

Confidence interval

Notes
[40] - Testing of hypotheses on efficacy parameters was conducted for exploratory purposes and P-values were calculated without multiplicity adjustment for multiple endpoints. Appropriate parametric and/or nonparametric statistics were applied. All tests were two-sided. A P-value of <0.05 indicated a significant difference between the two treatment groups in the parameter of interest.
[41] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Heartburn Frequency at Daytime Wk 10 – Wk 8

Statistical analysis description

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[42]

P-value

= 0.125 ^[43]

Method

ANCOVA

Confidence interval

Notes
[42] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[43] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Regurgitation Frequency at Daytime Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[44]

P-value

= 0.588 ^[45]

Method

ANCOVA

Confidence interval

Notes
[44] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[45] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Regurgitation Frequency at Daytime Wk 10 –Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[46]

P-value

= 0.94 ^[47]

Method

ANCOVA

Confidence interval

Notes
[46] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[47] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Regurgitation Frequency at Daytime Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[48]

P-value

= 0.622 ^[49]

Method

ANCOVA

Confidence interval

Notes
[48] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[49] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Nausea Frequency at Daytime Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[50]

P-value

= 0.728 ^[51]

Method

ANCOVA

Confidence interval

Notes
[50] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[51] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Nausea Frequency at Daytime Wk 10 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[52]

P-value

= 0.715 ^[53]

Method

ANCOVA

Confidence interval

Notes
[52] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[53] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Nausea Frequency at Daytime Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[54]

P-value

= 0.868 ^[55]

Method

ANCOVA

Confidence interval

Notes
[54] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[55] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vomiting Frequency at Daytime Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[56]

P-value

= 0.104 ^[57]

Method

ANCOVA

Confidence interval

Notes
[56] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[57] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vomiting Frequency at Daytime Wk 10 – Baseline

Statistical analysis description

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[58]

P-value

= 0.039 ^[59]

Method

ANCOVA

Confidence interval

Notes
[58] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[59] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vomiting Frequency at Daytime Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[60]

P-value

= 0.038 ^[61]

Method

ANCOVA

Confidence interval

Notes
[60] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[61] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Epigastric Pain Frequency at Daytime Wk 8–Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[62]

P-value

= 0.986 ^[63]

Method

ANCOVA

Confidence interval

Notes
[62] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[63] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Epigastric Pain Frequency at Daytime Wk10–Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[64]

P-value

= 0.59 ^[65]

Method

ANCOVA

Confidence interval

Notes
[64] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[65] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Epigastric Frequency at Daytime Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[66]

P-value

= 0.513 ^[67]

Method

ANCOVA

Confidence interval

Notes
[66] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[67] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Other Frequency at Daytime Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[68]

P-value

= 0.412 ^[69]

Method

ANCOVA

Confidence interval

Notes
[68] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[69] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Other Frequency at Daytime Wk 10 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[70]

P-value

= 0.547 ^[71]

Method

ANCOVA

Confidence interval

Notes
[70] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[71] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Other Frequency at Daytime Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[72]

P-value

= 0.618 ^[73]

Method

ANCOVA

Confidence interval

Notes
[72] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[73] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Secondary: Change in Severity of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8

Top of page

End point title

Change in Severity of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8

End point description

Participants were instructed to start recording severity of GERD symptoms in the daily diary. The change in severity was computed as the difference between a given symptom week score and baseline score. The severity of GERD symptoms were recorded as the maximum severity of the symptom (heartburn, regurgitation, nausea, vomiting, and epigastric pain) each day as reported by the participant in their daily diary using the 5-point Likert scale. The participant was also able to choose two other symptoms of concern from a list of twenty possible symptoms. Intent-to-treat population included all participants in the Safety population who also had at least one post-baseline assessment.

End point type

Secondary

End point timeframe

Baseline (including Screening values) to Week 8 and Baseline (including Screening values) to Week 10

End point values	10 mg Rabeprazole sodium	20 mg Rabeprazole sodium
Number of subjects analysed	54	57
Units: Change in severity
arithmetic mean (standard deviation)
Heartburn Week 8 – Baseline (n = 48, 51)	-0.57 ± 0.815	-0.87 ± 0.768
Heartburn Week 10 – Baseline (n = 48, 52)	-0.46 ± 0.772	-0.63 ± 0.779
Heartburn Week 10 – Week 8 (n = 51, 54)	0.11 ± 0.382	0.23 ± 0.47
Regurgitation Week 8 – Baseline (n = 48, 51)	-0.39 ± 0.697	-0.42 ± 0.749
Regurgitation Week 10 – Baseline (n = 48, 52)	-0.31 ± 0.751	-0.31 ± 0.617
Regurgitation Week 10 – Week 8 (n = 51, 54)	0.07 ± 0.295	0.1 ± 0.318
Nausea Week 8 – Baseline (n = 48, 51)	-0.41 ± 0.706	-0.55 ± 0.704
Nausea Week 10 – Baseline (n = 48, 52)	-0.33 ± 0.714	-0.41 ± 0.794
Nausea Week 10 – Week 8 (n = 51, 54)	0.05 ± 0.358	0.12 ± 0.436
Vomiting Week 8 – Baseline (n = 48, 51)	-0.13 ± 0.518	-0.09 ± 0.346
Vomiting Week 10 – Baseline (n = 48, 52)	-0.12 ± 0.508	-0.02 ± 0.325
Vomiting Week 10 – Week 8 (n = 51, 54)	0 ± 0.109	0.06 ± 0.202
Epigastric Pain Week 8 – Baseline (n = 48, 51)	-0.4 ± 0.574	-0.59 ± 0.681
Epigastric Pain Week 10 – Baseline (n = 48, 52)	-0.37 ± 0.57	-0.52 ± 0.665
Epigastric Pain Week 10 – Week 8 (n = 51, 54)	0 ± 0.24	0.05 ± 0.195
Other Week 8 – Baseline (n = 38, 45)	-0.74 ± 0.725	-0.81 ± 0.746
Other Week 10 – Baseline (n = 38, 45)	-0.66 ± 0.715	-0.63 ± 0.745
Other Week 10 – Week 8 (n = 43, 49)	0.04 ± 0.381	0.16 ± 0.318

Heartburn Frequency Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[74]

P-value

= 0.431 ^[75]

Method

ANCOVA

Confidence interval

Notes
[74] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[75] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Heartburn Frequency Wk 10 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[76]

P-value

= 0.628 ^[77]

Method

ANCOVA

Confidence interval

Notes
[76] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[77] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Heartburn Frequency Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[78]

P-value

= 0.117 ^[79]

Method

ANCOVA

Confidence interval

Notes
[78] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[79] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Regurgitation Frequency Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[80]

P-value

= 0.753 ^[81]

Method

ANCOVA

Confidence interval

Notes
[80] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[81] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Regurgitation Frequency Wk 10 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[82]

P-value

= 0.707 ^[83]

Method

ANCOVA

Confidence interval

Notes
[82] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[83] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Regurgitation Frequency Wk 10 – Wk 8

Statistical analysis description

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[84]

P-value

= 0.941 ^[85]

Method

ANCOVA

Confidence interval

Notes
[84] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[85] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Nausea Frequency Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[86]

P-value

= 0.368 ^[87]

Method

ANCOVA

Confidence interval

Notes
[86] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[87] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Nausea Frequency Wk 10 – Baseline

Statistical analysis description

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[88]

P-value

= 0.852 ^[89]

Method

ANCOVA

Confidence interval

Notes
[88] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[89] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Nausea Frequency Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[90]

P-value

= 0.795 ^[91]

Method

ANCOVA

Confidence interval

Notes
[90] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[91] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vomiting Frequency Wk 8 – Baseline

Statistical analysis description

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[92]

P-value

= 0.468 ^[93]

Method

ANCOVA

Confidence interval

Notes
[92] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[93] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vomiting Frequency Wk 10 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[94]

P-value

= 0.023 ^[95]

Method

ANCOVA

Confidence interval

Notes
[94] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[95] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vomiting Frequency Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[96]

P-value

= 0.031 ^[97]

Method

ANCOVA

Confidence interval

Notes
[96] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[97] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Epigastric Pain Frequency Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[98]

P-value

= 0.66 ^[99]

Method

ANCOVA

Confidence interval

Notes
[98] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[99] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Epigastric Pain Frequency Wk 10 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[100]

P-value

= 0.738 ^[101]

Method

ANCOVA

Confidence interval

Notes
[100] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[101] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Epigastric Pain Frequency Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[102]

P-value

= 0.528 ^[103]

Method

ANCOVA

Confidence interval

Notes
[102] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[103] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Other Frequency Wk 8 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[104]

P-value

= 0.377 ^[105]

Method

ANCOVA

Confidence interval

Notes
[104] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[105] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Other Frequency Wk 10 – Baseline

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[106]

P-value

= 0.914 ^[107]

Method

ANCOVA

Confidence interval

Notes
[106] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[107] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Other Frequency Wk 10 – Wk 8

Statistical analysis description

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[108]

P-value

= 0.17 ^[109]

Method

ANCOVA

Confidence interval

Notes
[108] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[109] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Secondary: Percentage of Participants Who Took Six or Fewer Antacids Per Day

Top of page

End point title

Percentage of Participants Who Took Six or Fewer Antacids Per Day

End point description

A 2-week supply of antacids was dispensed at the Screening and Baseline Visits. At the Baseline Visit, participants were instructed to begin completing daily drug administration diaries with the time of medication dosing and to note any rescue antacids (number of tablets in each 24-hour period) or other concomitant medications used. The participant responded to the question “Did participant take 6 or fewer antacids per day?” The shift in antacid use at postbaseline visits were compared to baseline. The ITT population was used and included all participants in the Safety population who also had at least one post-baseline assessment.

End point type

Secondary

End point timeframe

Baseline to Week 2, Baseline to Week 4, Baseline to Week 6, Baseline to Week 8, and Baseline to Week 10

End point values	10 mg Rabeprazole sodium	20 mg Rabeprazole sodium
Number of subjects analysed	41	42
Units: Percentage of participants
number (not applicable)
Baseline - Yes	100	97.7
Baseline - No	0	2.3
Week 2 - Yes	98.1	100
Week 2 - No	1.9	0
Week 4 - Yes	100	100
Week 4 - No	0	0
Week 6 - Yes	100	98.1
Week 6 - No	0	1.9
Week 8 - Yes	100	98.2
Week 8 - No	0	1.8
Week 10 - Yes	100	98.1
Week 10 - No	0	1.9

No statistical analyses for this end point

Secondary: Change from Baseline in the Psychological General Well-Being Index (PGWBI) Scores

Top of page

End point title

Change from Baseline in the Psychological General Well-Being Index (PGWBI) Scores

End point description

At the bi-weekly study center visit, a quality of life (QOL) assessment was conducted using the PSWBI scales, which has been validated in ages 12 years and older. Change in quality of life domains was computed as QOL domain score at a given week visit minus baseline score. The PGWBI is composed of 22 items and was analyzed to 7 dimensions; Anxiety (ANX) (score range 0-25), Depressed Mood (DEP) (score range 0-15), Positive well-being (PWB) (score range 0-20), Self-control (SC) (score range 0-15), General Health (GH) (score range 0-15), Vitality (VT) (score range 0-20), and Raw Index Score (score range 0-110). Each item in the questionnaire has a 6-point scale from 0-5 where a higher score indicates a more positive rating and a lower score means a more negative rating. The ITT population was used and included all participants in the Safety population who also had at least one post-baseline assessment.

End point type

Secondary

End point timeframe

Baseline, Weeks 2, 4, 6, 8, and 10

End point values	10 mg Rabeprazole sodium	20 mg Rabeprazole sodium
Number of subjects analysed	54	57
Units: Scores on a scale
arithmetic mean (standard deviation)
Anxiety; Week 2 - Baseline (n = 47, 50)	4.9 ± 16.95	5.6 ± 17.52
Anxiety; Week 4 - Baseline (n = 51, 52)	5.8 ± 17.01	9 ± 14.98
Anxiety; Week 6 - Baseline (n = 52, 51)	8.5 ± 16.19	8.8 ± 17.51
Anxiety; Week 8 - Baseline (n = 52, 54)	11 ± 15.3	7.8 ± 17.42
Anxiety; Week 10 - Baseline (n = 48, 52)	10 ± 16.19	9.7 ± 18.12
Depressed mood; Week 2 - Baseline (n = 47, 50)	4.8 ± 12.33	2.5 ± 13.12
Depressed mood; Week 4 - Baseline (n = 51, 52)	5.2 ± 12.81	2.3 ± 13.96
Depressed mood; Week 6 - Baseline (n = 52, 51)	6.7 ± 14.94	5 ± 16.16
Depressed mood; Week 8 - Baseline (n = 52, 54)	6.5 ± 16.03	2.8 ± 18.97
Depressed mood; Week 10 - Baseline (n = 48, 52)	5.4 ± 15.72	5.5 ± 18.09
Positive well-being; Week 2 - Baseline (n= 47, 50)	4.6 ± 13.51	2.9 ± 14.25
Positive well-being; Week 4 - Baseline (n= 51, 52)	5.8 ± 16.47	4.9 ± 17.05
Positive well-being; Week 6 - Baseline (n= 52, 51)	8.8 ± 16.97	8.3 ± 17.25
Positive well-being; Week 8 - Baseline (n= 52, 54)	9.1 ± 18.22	8.9 ± 19.37
Positive well-being; Week 10 - Baseline (n=48, 52)	8.1 ± 16.9	8.5 ± 18.41
Self control; Week 2 - Baseline (n = 47, 50)	2.3 ± 16.98	1.9 ± 10.17
Self control; Week 4 - Baseline (n = 51, 52)	2 ± 18.87	2.6 ± 10.57
Self control; Week 6 - Baseline (n = 52, 51)	7.6 ± 19.13	4.8 ± 11.71
Self control; Week 8 - Baseline (n = 52, 54)	4.7 ± 21.05	3 ± 13.93
Self control; Week 10 - Baseline (n = 48, 52)	5.6 ± 16.52	4.9 ± 15.57
General health; Week 2 - Baseline (n = 47, 50)	7 ± 16.56	7.5 ± 16.64
General health; Week 4 - Baseline (n = 51, 52)	9.8 ± 16.13	9.1 ± 13.66
General health; Week 6 - Baseline (n = 52, 51)	14.1 ± 13.57	8.6 ± 17.85
General health; Week 8 - Baseline (n = 52, 54)	12.1 ± 16.39	11.6 ± 15.33
General health; Week 10 - Baseline (n = 48, 52)	11.1 ± 13.84	9.1 ± 14.94
Vitality; Week 2 - Baseline (n = 47, 50)	0.2 ± 14.82	6.7 ± 15.34
Vitality; Week 4 - Baseline (n = 51, 52)	1.1 ± 17.42	8 ± 19.08
Vitality; Week 6 - Baseline (n = 52, 51)	4.2 ± 13.45	10.9 ± 19.07
Vitality; Week 8 - Baseline (n = 52, 54)	4.9 ± 17.16	10.3 ± 19.84
Vitality; Week 10 - Baseline (n = 48, 52)	4.7 ± 18.52	9.4 ± 20.71
Raw index score; Week 2 - baseline (n = 47, 50)	3.9 ± 11.16	4.6 ± 10.3
Raw index score; Week 4 - baseline (n = 51, 52)	4.9 ± 12.09	6.3 ± 10.36
Raw index score; Week 6 - baseline (n = 52, 51)	8.2 ± 10.3	8 ± 11.52
Raw index score; Week 8 - baseline (n = 52, 54)	8.2 ± 11.98	7.6 ± 13.25
Raw index score; Week 10 - baseline (n = 48, 52)	7.6 ± 12.06	8.1 ± 13.58

Anxiety; Week 2 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[110]

P-value

= 0.658 ^[111]

Method

ANCOVA

Confidence interval

Notes
[110] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[111] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Anxiety; Week 4 - Baseline

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[112]

P-value

= 0.152 ^[113]

Method

ANCOVA

Confidence interval

Notes
[112] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[113] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Anxiety; Week 6 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[114]

P-value

= 0.245 ^[115]

Method

ANCOVA

Confidence interval

Notes
[114] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[115] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Anxiety; Week 8 - Baseline

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[116]

P-value

= 0.564 ^[117]

Method

ANCOVA

Confidence interval

Notes
[116] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[117] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Anxiety; Week 10 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[118]

P-value

= 0.226 ^[119]

Method

ANCOVA

Confidence interval

Notes
[118] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[119] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Depressed mood; Week 2 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[120]

P-value

= 0.671 ^[121]

Method

ANCOVA

Confidence interval

Notes
[120] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[121] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Depressed mood; Week 4 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[122]

P-value

= 0.833 ^[123]

Method

ANCOVA

Confidence interval

Notes
[122] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[123] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Depressed mood; Week 6 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[124]

P-value

= 0.395 ^[125]

Method

ANCOVA

Confidence interval

Notes
[124] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[125] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Depressed mood; Week 8 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[126]

P-value

= 0.835 ^[127]

Method

ANCOVA

Confidence interval

Notes
[126] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[127] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Depressed mood; Week 10 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[128]

P-value

= 0.147 ^[129]

Method

ANCOVA

Confidence interval

Notes
[128] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[129] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Positive well-being; Week 2 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[130]

P-value

= 0.675 ^[131]

Method

ANCOVA

Confidence interval

Notes
[130] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[131] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Positive well-being; Week 4 - Baseline

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[132]

P-value

= 0.226 ^[133]

Method

ANCOVA

Confidence interval

Notes
[132] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[133] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Positive well-being; Week 6 - Baseline

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[134]

P-value

= 0.075 ^[135]

Method

ANCOVA

Confidence interval

Notes
[134] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[135] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Positive well-being; Week 8 - Baseline

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[136]

P-value

= 0.123 ^[137]

Method

ANCOVA

Confidence interval

Notes
[136] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[137] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Positive well-being; Week 10 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[138]

P-value

= 0.17 ^[139]

Method

ANCOVA

Confidence interval

Notes
[138] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[139] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Self control; Week 2 - Baseline

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[140]

P-value

= 0.234 ^[141]

Method

ANCOVA

Confidence interval

Notes
[140] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[141] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Self control; Week 4 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[142]

P-value

= 0.112 ^[143]

Method

ANCOVA

Confidence interval

Notes
[142] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[143] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Self control; Week 6 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[144]

P-value

= 0.421 ^[145]

Method

ANCOVA

Confidence interval

Notes
[144] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[145] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Self control; Week 8 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[146]

P-value

= 0.524 ^[147]

Method

ANCOVA

Confidence interval

Notes
[146] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[147] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Self control; Week 10 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[148]

P-value

= 0.412 ^[149]

Method

ANCOVA

Confidence interval

Notes
[148] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[149] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

General health; Week 2 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[150]

P-value

= 0.742 ^[151]

Method

ANCOVA

Confidence interval

Notes
[150] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[151] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

General health; Week 4 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[152]

P-value

= 0.765 ^[153]

Method

ANCOVA

Confidence interval

Notes
[152] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[153] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

General health; Week 6 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[154]

P-value

= 0.266 ^[155]

Method

ANCOVA

Confidence interval

Notes
[154] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[155] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

General health; Week 8 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[156]

P-value

= 0.388 ^[157]

Method

ANCOVA

Confidence interval

Notes
[156] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[157] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

General health; Week 10 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[158]

P-value

= 0.849 ^[159]

Method

ANCOVA

Confidence interval

Notes
[158] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[159] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vitality; Week 2 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[160]

P-value

= 0.026 ^[161]

Method

ANCOVA

Confidence interval

Notes
[160] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[161] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vitality; Week 4 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[162]

P-value

= 0.031 ^[163]

Method

ANCOVA

Confidence interval

Notes
[162] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[163] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vitality; Week 6 - Baseline

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[164]

P-value

= 0.011 ^[165]

Method

ANCOVA

Confidence interval

Notes
[164] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[165] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vitality; Week 8 - Baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[166]

P-value

= 0.026 ^[167]

Method

ANCOVA

Confidence interval

Notes
[166] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[167] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Vitality; Week 10 - Baseline

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[168]

P-value

= 0.073 ^[169]

Method

ANCOVA

Confidence interval

Notes
[168] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[169] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Raw index score; Week 2 - baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[170]

P-value

= 0.367 ^[171]

Method

ANCOVA

Confidence interval

Notes
[170] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[171] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Raw index score; Week 4 - baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[172]

P-value

= 0.181 ^[173]

Method

ANCOVA

Confidence interval

Notes
[172] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[173] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Raw index score; Week 6 - baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[174]

P-value

= 0.196 ^[175]

Method

ANCOVA

Confidence interval

Notes
[174] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[175] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Raw index score; Week 8 - baseline

Comparison groups

20 mg Rabeprazole sodium v 10 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[176]

P-value

= 0.382 ^[177]

Method

ANCOVA

Confidence interval

Notes
[176] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[177] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Raw index score; Week 10 - baseline

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[178]

P-value

= 0.138 ^[179]

Method

ANCOVA

Confidence interval

Notes
[178] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[179] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Secondary: Change from Baseline in the Medical Outcomes Study 10-item Short form Questionnaire (SF-10) Scores

Top of page

End point title

Change from Baseline in the Medical Outcomes Study 10-item Short form Questionnaire (SF-10) Scores

End point description

At the bi-weekly study center visit, a quality of life (QOL) assessment was conducted using a pediatric form of the SF-10 scales, which has been validated for children ages 12 years and older. Change in quality of life domains was computed as QOL domain score at a given week visit minus baseline score. This was a 10-item questionnaire in which scores were analyzed based on two main categories, Physical and Psychological summary scores. A higher score indicates more favorable physical and psychological functioning. The ITT population was used and included all participants in the Safety population who also had at least one post-baseline assessment.

End point type

Secondary

End point timeframe

Screening Visit, Baseline Visit (if greater than 72 hours after Screening), Weeks 2, 4, 6, 8, and 10

End point values	10 mg Rabeprazole sodium	20 mg Rabeprazole sodium
Number of subjects analysed	54	57
Units: Scores on a scale
arithmetic mean (standard deviation)
Physical summary score Week 2 (n = 48, 50)	3.7 ± 8.47	2 ± 10.67
Physical summary score Week 4 (n = 49, 51)	3 ± 7.1	3.9 ± 9.42
Physical summary score Week 6 (n = 50, 54)	3.7 ± 8.65	4.5 ± 11.07
Physical summary score Week 8 (n = 50, 54)	2.9 ± 7.75	4.4 ± 10.58
Physical summary score Week 10 (n = 47, 53)	3.8 ± 6.53	4.3 ± 9.45
Psychological summary score Week 2 (n = 48, 50)	3.1 ± 8.85	-0.2 ± 10.15
Psychological summary score Week 4 (n = 49, 51)	2.8 ± 9.05	1.9 ± 7.74
Psychological summary score Week 6 (n = 50, 54)	2.7 ± 9.35	2.5 ± 7.24
Psychological summary score Week 8 (n = 50, 54)	3.7 ± 9.57	2.1 ± 8.33
Psychological summary score Week 10 (n = 47, 53)	3.6 ± 10.39	1.8 ± 9.43

Physical summary score Week 2

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[180]

P-value

= 0.054 ^[181]

Method

ANCOVA

Confidence interval

Notes
[180] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[181] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Physical summary score Week 4

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[182]

P-value

= 0.955 ^[183]

Method

ANCOVA

Confidence interval

Notes
[182] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[183] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Physical summary score Week 6

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[184]

P-value

= 0.8 ^[185]

Method

ANCOVA

Confidence interval

Notes
[184] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[185] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Physical summary score Week 8

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[186]

P-value

= 0.641 ^[187]

Method

ANCOVA

Confidence interval

Notes
[186] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[187] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Physical summary score Week 10

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[188]

P-value

= 0.783 ^[189]

Method

ANCOVA

Confidence interval

Notes
[188] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[189] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Psychological summary score Week 2

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[190]

P-value

= 0.139 ^[191]

Method

ANCOVA

Confidence interval

Notes
[190] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[191] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Psychological summary score Week 4

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[192]

P-value

= 0.876 ^[193]

Method

ANCOVA

Confidence interval

Notes
[192] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[193] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Psychological summary score Week 6

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[194]

P-value

= 0.236 ^[195]

Method

ANCOVA

Confidence interval

Notes
[194] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[195] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Psychological summary score Week 8

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[196]

P-value

= 0.608 ^[197]

Method

ANCOVA

Confidence interval

Notes
[196] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[197] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Psychological summary score Week 10

Comparison groups

10 mg Rabeprazole sodium v 20 mg Rabeprazole sodium

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

other ^[198]

P-value

= 0.697 ^[199]

Method

ANCOVA

Confidence interval

Notes
[198] - This was an open-label trial testing two dosages of rabeprazole sodium for safety and efficacy.
[199] - P-value from ANCOVA taking treatment and center as fixed factors, and baseline values as covariates. P-values reported as statistically significant (ie, P<0.05) were not adjusted for multiplicity and therefore should be interpreted with caution.

Adverse events

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Timeframe for reporting adverse events

Adverse events were collected for up to 12 weeks.

Adverse event reporting additional description

Treatment-emergent adverse events were reported. The Safety Population was used and included all participants who received at least 1 dose of study treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

8.0

Reporting group title

20 mg Rabeprazole sodium

Reporting group description

Reporting group title

10 mg Rabeprazole sodium

Reporting group description

Serious adverse events	20 mg Rabeprazole sodium	10 mg Rabeprazole sodium
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 57 (1.75%)	0 / 54 (0.00%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events
Psychiatric disorders
Mood swings
subjects affected / exposed	1 / 57 (1.75%)	0 / 54 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	20 mg Rabeprazole sodium	10 mg Rabeprazole sodium
Total subjects affected by non serious adverse events
subjects affected / exposed	26 / 57 (45.61%)	21 / 54 (38.89%)
Nervous system disorders
Headache
subjects affected / exposed	6 / 57 (10.53%)	5 / 54 (9.26%)
occurrences all number	6	6
General disorders and administration site conditions
Chest pain
subjects affected / exposed	3 / 57 (5.26%)	0 / 54 (0.00%)
occurrences all number	3	0
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	3 / 57 (5.26%)	1 / 54 (1.85%)
occurrences all number	3	1
Diarrhoea
subjects affected / exposed	2 / 57 (3.51%)	3 / 54 (5.56%)
occurrences all number	2	3
Nausea
subjects affected / exposed	2 / 57 (3.51%)	3 / 54 (5.56%)
occurrences all number	2	3
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	3 / 57 (5.26%)	5 / 54 (9.26%)
occurrences all number	3	5
Nasal congestion
subjects affected / exposed	4 / 57 (7.02%)	4 / 54 (7.41%)
occurrences all number	4	4
Pharyngolaryngeal pain
subjects affected / exposed	5 / 57 (8.77%)	6 / 54 (11.11%)
occurrences all number	5	6
Infections and infestations
Bronchitis
subjects affected / exposed	2 / 57 (3.51%)	3 / 54 (5.56%)
occurrences all number	2	3
Nasopharyngitis
subjects affected / exposed	4 / 57 (7.02%)	1 / 54 (1.85%)
occurrences all number	4	1
Otitis media
subjects affected / exposed	3 / 57 (5.26%)	1 / 54 (1.85%)
occurrences all number	3	1
Pharyngitis
subjects affected / exposed	2 / 57 (3.51%)	3 / 54 (5.56%)
occurrences all number	2	3
Sinusitis
subjects affected / exposed	3 / 57 (5.26%)	2 / 54 (3.70%)
occurrences all number	4	2
Upper respiratory tract infection
subjects affected / exposed	3 / 57 (5.26%)	4 / 54 (7.41%)
occurrences all number	3	4

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Summary of Adverse Events (AEs)

Primary: Summary of Adverse Events (AEs)

Secondary: Change in Frequency of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8 at Nighttime

Secondary: Change in Frequency of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8 at Nighttime

Secondary: Change in Frequency of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8 at Daytime

Secondary: Change in Frequency of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8 at Daytime

Secondary: Change in Severity of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8

Secondary: Change in Severity of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8

Secondary: Percentage of Participants Who Took Six or Fewer Antacids Per Day

Secondary: Percentage of Participants Who Took Six or Fewer Antacids Per Day

Secondary: Change from Baseline in the Psychological General Well-Being Index (PGWBI) Scores

Secondary: Change from Baseline in the Psychological General Well-Being Index (PGWBI) Scores

Secondary: Change from Baseline in the Medical Outcomes Study 10-item Short form Questionnaire (SF-10) Scores

Secondary: Change from Baseline in the Medical Outcomes Study 10-item Short form Questionnaire (SF-10) Scores

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Clinical trials

Clinical Trial Results: Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Summary of Adverse Events (AEs)

Primary: Summary of Adverse Events (AEs)

Secondary: Change in Frequency of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8 at Nighttime

Secondary: Change in Frequency of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8 at Nighttime

Secondary: Change in Frequency of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8 at Daytime

Secondary: Change in Frequency of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8 at Daytime

Secondary: Change in Severity of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8

Secondary: Change in Severity of GERD Symptoms Between Baseline and Weeks 8 and 10 and Between Week 10 and Week 8

Secondary: Percentage of Participants Who Took Six or Fewer Antacids Per Day

Secondary: Percentage of Participants Who Took Six or Fewer Antacids Per Day

Secondary: Change from Baseline in the Psychological General Well-Being Index (PGWBI) Scores

Secondary: Change from Baseline in the Psychological General Well-Being Index (PGWBI) Scores

Secondary: Change from Baseline in the Medical Outcomes Study 10-item Short form Questionnaire (SF-10) Scores

Secondary: Change from Baseline in the Medical Outcomes Study 10-item Short form Questionnaire (SF-10) Scores

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients