Clinical Trial Results:
A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Infants Aged 1 to 11 Months, Inclusive
Summary
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EudraCT number |
2006-005212-27 |
Trial protocol |
FR DE Outside EU/EEA |
Global end of trial date |
23 Sep 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Nov 2016
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First version publication date |
18 Nov 2016
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
D9614C00096
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
AstraZeneca LP
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Sponsor organisation address |
1800 Concord Pike, Wilmington, Delaware, United States, 19850
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Public contact |
AZ Clinical Trial Transparency group, AstraZeneca R&D, ClinicalTrialTransparency@astrazeneca.com
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Scientific contact |
Gerard Lynch, AstraZeneca R&D, AZTrial_Results_Posting@astrazeneca.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000331-PIP01-08 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Sep 2008
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Sep 2008
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Sep 2008
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study was to evaluate the efficacy of once daily esomeprazole for reducing the esophageal and supraesophageal signs and symptoms of infantile gastroesophageal reflux disease (GERD).
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Protection of trial subjects |
The study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with ICH/Good Clinical Practice and applicable regulatory requirements and the AstraZeneca policy on Bioethics.The final clinical study protocol (CSP), including the final version of the Informed Consent Form, was approved or given a favorable opinion in writing by an Ethics Committee as appropriate. The investigator submitted written approval to AstraZeneca before he or she enrolled any patient into the study. The principal investigator(s) at each center ensured that the patient’s parent/guardian was given full and adequate oral and written information about the nature, purpose, possible risk and benefit of the study. The parent/guardian was also notified that they were free to discontinue his/her child from the study at any time. The patient’s parent/guardian was given the opportunity to ask questions and allowed time to consider the information provided.
The parent/guardian’s signed and dated informed consent was obtained before conducting any procedure specifically for the study.
Patients could be discontinued from study treatment and assessments at any time, at the discretion of the investigator(s).
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Background therapy |
PPI within 7 days, or H2RAs or prokinetics within 24 hours prior to enrollment in the open label treatment phase were exclusion criteria. | ||
Evidence for comparator |
No comparator | ||
Actual start date of recruitment |
12 Apr 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 15
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Country: Number of subjects enrolled |
Germany: 16
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Country: Number of subjects enrolled |
Poland: 30
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Country: Number of subjects enrolled |
United States: 37
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Worldwide total number of subjects |
98
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EEA total number of subjects |
61
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
98
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants aged 1 to 11 months inclusive with a clinical diagnosis of suspected Gastroesophageal Reflux Disease (GERD), symptomatic GERD, or endoscopically proven GERD enrolled First patient enrolled: 12 April 2007 Last patient completed: 4 June 2008 | ||||||||||||||||||
Pre-assignment
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Screening details |
Of 103 patients screened for this study, 5 patients failed to be eligible. In total, 98 patients were entered into the open-label esomeprazole phase. Of these, 80 were randomized into the double-blind randomized phase. | ||||||||||||||||||
Period 1
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Period 1 title |
Open-label treatment phase
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Is this the baseline period? |
No | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
Arms
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Arm title
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Open Label Esomeprazole | ||||||||||||||||||
Arm description |
Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight). Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Esomeprazole magnesium
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Investigational medicinal product code |
|||||||||||||||||||
Other name |
NEXIUM
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
0.5-1.3 mg/kg od orally
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Period 2
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Period 2 title |
Double-blind, treatment-withdrawal phase
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Is this the baseline period? |
Yes [1] | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Data analyst, Assessor | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Double Blind Esomeprazole | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Esomeprazole magnesium
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Investigational medicinal product code |
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Other name |
NEXIUM
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
0.5-1.3 mg/kg od orally
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Arm title
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Double Blind Placebo | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
Placebo
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
0.5-1.3 mg/kg od orally
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Notes [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period. Justification: Amongst the 98 patients who entered the open-label period 18 did not qualify to be randomized into the double-blinded period. All baseline characteristics were reported on the 80 patients randomized into the Double-Blind Randomized Period |
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Notes [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Amongst the 98 patients who entered the open-label period 18 did not qualify to be randomized into the double-blinded period. All baseline characteristics were reported on the 80 patients randomized into the Double-Blind Randomized Period |
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Baseline characteristics reporting groups
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Reporting group title |
Double Blind Esomeprazole
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Double Blind Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Open label treatment phase
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Open label treatment phase
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Subject analysis set title |
Double-blind phase esomeprazole
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Double-blind phase esomeprazole
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Subject analysis set title |
Double-blind phase placebo
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Double-blind phase placebo
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End points reporting groups
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Reporting group title |
Open Label Esomeprazole
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Reporting group description |
Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight). Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase. | ||
Reporting group title |
Double Blind Esomeprazole
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Reporting group description |
- | ||
Reporting group title |
Double Blind Placebo
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Reporting group description |
- | ||
Subject analysis set title |
Open label treatment phase
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Open label treatment phase
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Subject analysis set title |
Double-blind phase esomeprazole
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Double-blind phase esomeprazole
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Subject analysis set title |
Double-blind phase placebo
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Double-blind phase placebo
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End point title |
Number of participants discontinuing due to symptom worsening in the randomized treatment withdrawal phase (Treatment withdrawal phase endpoint) | |||||||||||||||||||||||||||||||||||
End point description |
Number of participants discontinuing during the 4-week of randomized double-blind withdrawal phase that met the pre-set definition of symptom worsening criteria.
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End point type |
Primary
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End point timeframe |
Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
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Statistical analysis title |
Analysis of time to discontinuation | |||||||||||||||||||||||||||||||||||
Statistical analysis description |
Analysis of time to discontinuation due to symptom worsening.
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Comparison groups |
Double Blind Esomeprazole v Double Blind Placebo v Double-blind phase esomeprazole v Double-blind phase placebo
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Number of subjects included in analysis |
160
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||||||||||||||||
P-value |
= 0.2751 | |||||||||||||||||||||||||||||||||||
Method |
Regression, Cox | |||||||||||||||||||||||||||||||||||
Parameter type |
Hazard ratio (HR) | |||||||||||||||||||||||||||||||||||
Point estimate |
0.69
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Confidence interval |
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level |
95% | |||||||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.35 | |||||||||||||||||||||||||||||||||||
upper limit |
1.35 | |||||||||||||||||||||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.4
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End point title |
Number of participants discontinuing due to any reason, including symptom worsening, in the randomized treatment withdrawal phase (Treatment withdrawal phase endpoint) | |||||||||||||||||||||||||||||||||||
End point description |
Number of participants discontinuing due to any reason was identical to the number of participants discontinuing due to symptom worsening (the primary assessment) when no participants discontinued due to reason other than symptom worsening.
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End point type |
Secondary
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End point timeframe |
Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
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Statistical analysis title |
Time to discontinuation due to any reason | |||||||||||||||||||||||||||||||||||
Comparison groups |
Double Blind Esomeprazole v Double Blind Placebo v Double-blind phase esomeprazole v Double-blind phase placebo
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Number of subjects included in analysis |
160
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||||||||||||||||
P-value |
= 0.2751 | |||||||||||||||||||||||||||||||||||
Method |
Regression, Cox | |||||||||||||||||||||||||||||||||||
Parameter type |
Hazard ratio (HR) | |||||||||||||||||||||||||||||||||||
Point estimate |
0.69
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Confidence interval |
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level |
95% | |||||||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.35 | |||||||||||||||||||||||||||||||||||
upper limit |
1.35 | |||||||||||||||||||||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.4
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End point title |
Treatment successes at the end of the 4-week double-blind treatment withdrawal phase (Treatment withdrawal phase endpoint). | |||||||||||||||
End point description |
The number of participants reaching the end of the treatment withdrawal phase without discontinuing from the study (for any reason) or showing symptom worsening in the physician global assessment of Gastroesophageal Reflux Disease (GERD) symptoms. Based on the severity of symptoms reported by the parent/guardian in IVRS, the investigator provided the overall clinical impression of the patient’s GERD-related symptoms over the last 7 days as: None Mild Moderate Severe
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End point type |
Secondary
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End point timeframe |
Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
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Statistical analysis title |
Analysis of the number of responders | |||||||||||||||
Statistical analysis description |
Analysis of the number of treatment responders at the end of the double-blind phase
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Comparison groups |
Double Blind Esomeprazole v Double Blind Placebo v Double-blind phase esomeprazole v Double-blind phase placebo
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Number of subjects included in analysis |
160
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.3524 | |||||||||||||||
Method |
Chi-squared | |||||||||||||||
Parameter type |
Odds ratio (OR) | |||||||||||||||
Point estimate |
1.524
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
0.626 | |||||||||||||||
upper limit |
3.709 | |||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.45
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End point title |
Physician's Global Assessment (PGA) of Gastroesophageal Reflux Disease (GERD) symptoms (Treatment withdrawal phase endpoint) | ||||||||||||||||||||||||||||||||||||||||
End point description |
Percentage of participants with Physician's Global Assessment (PGA) score at the final treatment withdrawal assessment in following categories: None (no symptoms), Mild, Moderate or Severe. The worst post-randomization Physician's Global Assessment (PGA) assessment during double blind phase is taken into account.
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End point type |
Secondary
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End point timeframe |
Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
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No statistical analyses for this end point |
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End point title |
Severity of Vomiting/regurgitation symptoms as reported by the parent/guardian (Treatment withdrawal phase endpoint) | ||||||||||||||||||||
End point description |
Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.
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End point type |
Secondary
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End point timeframe |
Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained
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No statistical analyses for this end point |
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End point title |
Severity of irritability crying/fussing symptoms as reported by the parent/guardian (Treatment withdrawal phase endpoint) | ||||||||||||||||||||
End point description |
Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.
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End point type |
Secondary
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End point timeframe |
Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained
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No statistical analyses for this end point |
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End point title |
Severity of supraesophageal/respiratory disturbances (coughing/wheezing,labored breathing) as reported by parent/guardian (Treatment withdrawal phase endpoint) | ||||||||||||||||||||
End point description |
Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.
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End point type |
Secondary
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End point timeframe |
Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained
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No statistical analyses for this end point |
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End point title |
Severity of feeding difficulties reported by parent/guardian (Treatment withdrawal phase endpoint) | ||||||||||||||||||||
End point description |
Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.
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End point type |
Secondary
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End point timeframe |
Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained
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No statistical analyses for this end point |
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End point title |
Improvement in Physician's Global Assessment (PGA) following open-label esomeprazole (Open-label phase endpoint) | |||||||||
End point description |
Number of patients who had an improvement of at least one category in the PGA at the end of open-label treatment with esomeprazole compared to baseline. Improvement in PGA was a pre-requisite for randomization into the randomized treatment withdrawal phase. Only patients with PGA at baseline and end of open-label are analyzed here.
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End point type |
Secondary
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End point timeframe |
Open-label treatment period (2 weeks)
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No statistical analyses for this end point |
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End point title |
Severity of Vomiting/regurgitation symptoms as reported by the parent/guardian (Open-label phase) | |||||||||||||||||||||
End point description |
Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.
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End point type |
Secondary
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End point timeframe |
Open Label phase (Screening plus two weeks)
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No statistical analyses for this end point |
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End point title |
Severity of irritability crying/fussing symptoms as reported by the parent/guardian (Open-label phase endpoint) | |||||||||||||||||||||
End point description |
Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.
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End point type |
Secondary
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End point timeframe |
Open Label Phase (Screening plus two weeks)
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No statistical analyses for this end point |
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End point title |
Severity of supraesophageal/respiratory disturbances (coughing/wheezing,labored breathing) as reported by parent/guardian (Open-label phase endpoint) | |||||||||||||||||||||
End point description |
Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.
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End point type |
Secondary
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End point timeframe |
Open Label Phase (Screening plus two weeks)
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No statistical analyses for this end point |
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End point title |
Severity of feeding difficulties as reported by parent/guardian (Open-label phase endpoint) | |||||||||||||||||||||
End point description |
Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.
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End point type |
Secondary
|
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End point timeframe |
Open Label Phase (Screening plus two weeks)
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
During openlabel phase 2 weeks and doubleblind randomised treatment 4 weeks.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11.0
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Reporting groups
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Reporting group title |
Open-label phase
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Reporting group description |
Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Double Blind Esomeprazole
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Reporting group description |
Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Double Blind Placebo
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Reporting group description |
Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|
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Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |