Clinical Trial Results:
A Phase III, Multicenter, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years, Inclusive
Summary
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EudraCT number |
2012-001136-61 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
19 Sep 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Feb 2017
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First version publication date |
16 Aug 2015
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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 |
D9614C00098
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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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 |
Marta Illueca, MD, FAAP, AstraZeneca LP, 1 302-885-5514,
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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 |
19 Sep 2008
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Sep 2008
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Global end of trial reached? |
Yes
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Global end of trial date |
19 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 safety and tolerability of once daily treatment with esomeprazole in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed 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 and all advertising used to recruit patients, had to be approved by an Institutional Review Board (IRB) before enrollment of any patient into the study.All patients (and their parents/guardians) were provided with all the information necessary to make an informed decision about their participation in the study, including the nature and intended purpose of the study, possible benefits and possible risks. All information in the informed consent form was provided in language understandable to the patients and their parents/guardians. The patient’s parent/guardian’s signed and dated informed consent as well as the patient’s signed and dated assent were obtained before conducting any procedure specifically for the study. If the patient or patient’s parents/guardians could not read, the informed consent form (or assent) was signed and dated by an impartial witness. The person who discussed the informed consent information with the patient also signed and dated the form.Patients could be discontinued from study treatment and assessments at any time, voluntary by the patient who was free to discontinue at anay time, or at the discretion of the investigator(s)
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Background therapy |
PPI use within 14 days prior to randomization (Visit 2), including over-the-counter (OTC) PRILOSEC® (AstraZeneca LP) was exclusion criteria, as was any prescription or OTC treatment use for symptoms of GERD, such as H2RA or prokinetics, within 3 days (72 hours) prior to randomization (Visit 2). Antacids were allowed, except for those containing bismuth. | ||
Evidence for comparator |
No comparator group | ||
Actual start date of recruitment |
20 Feb 2004
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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: 5
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Country: Number of subjects enrolled |
Italy: 1
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Country: Number of subjects enrolled |
Canada: 21
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Country: Number of subjects enrolled |
United States: 122
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Worldwide total number of subjects |
149
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EEA total number of subjects |
6
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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) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
149
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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 |
First patient enrolled: 20 February 2004 Last patient completed: 04 May 2005 | |||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Out of 157 patients screened for this study, 8 patients failed to be eligible and never received study medication. | |||||||||||||||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
149 | |||||||||||||||||||||||||||
Number of subjects completed |
149 | |||||||||||||||||||||||||||
Period 1
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Period 1 title |
Treatment (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||
Roles blinded |
Investigator, Monitor, Carer, Data analyst, Assessor, Subject | |||||||||||||||||||||||||||
Blinding implementation details |
Double-blind
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Esomeprazole 20 mg | |||||||||||||||||||||||||||
Arm description |
Esomeprazole magnesium 20 mg | |||||||||||||||||||||||||||
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 |
20 mg od orally
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Arm title
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Esomeprazole 40 mg | |||||||||||||||||||||||||||
Arm description |
Esomeprazole magnesium 40 mg | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Esomeprazole magnesium
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
40 mg od orally
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Baseline characteristics reporting groups
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Reporting group title |
Esomeprazole 20 mg
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Reporting group description |
Esomeprazole magnesium 20 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Esomeprazole 40 mg
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Reporting group description |
Esomeprazole magnesium 40 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
ITT
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
ITT
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End points reporting groups
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Reporting group title |
Esomeprazole 20 mg
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Reporting group description |
Esomeprazole magnesium 20 mg | ||
Reporting group title |
Esomeprazole 40 mg
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Reporting group description |
Esomeprazole magnesium 40 mg | ||
Subject analysis set title |
ITT
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
ITT
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End point title |
Number of patients whose Physician Global Assessment score improved from baseline at their final visit (ITT population) [1] | ||||||||||||
End point description |
Number of patients whose Physician's Globle Assessment score improved from baseline
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End point type |
Primary
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End point timeframe |
From baseline to final Visit
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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: Only Discriptive statistics are provided for the endpoints. |
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No statistical analyses for this end point |
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End point title |
Heartburn Symptom - average change from baseline at final week | ||||||||||||||||
End point description |
symptoms were rated on a 4-point scale as follows: 0=none; 1=mild; 2=moderate; 3=severe.
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End point type |
Secondary
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End point timeframe |
Baseline to final week
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Notes [2] - All patients who had heartburn symptoms at baseline [3] - All patients who had heartburn symptoms at baseline [4] - All patients who had heartburn symptoms at baseline |
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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 treatment (8weeks)
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
8.0
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Reporting groups
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Reporting group title |
Esomeprazole 40 mg
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Reporting group description |
Esomeprazole magnesium 40 mg | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Esomeprazole 20 mg
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Reporting group description |
Esomeprazole magnesium 20 mg | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |