- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00468559
Phase 3/Safety & Efficacy of Esomeprazole in Infants
A Phase 3, 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 (GERD) in Infants Aged 1 to 11 Months, Inclusive
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Lille Cedex, France
- Research Site
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Paris, France
- Research Site
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Bochum, Germany
- Research Site
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Greifswald, Germany
- Research Site
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Nurberg, Germany
- Research Site
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Potsdam, Germany
- Research Site
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Wuppertal, Germany
- Research Site
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Bialystok, Poland
- Research Site
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Krakow, Poland
- Research Site
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Warszawa, Poland
- Research Site
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Wroclaw, Poland
- Research Site
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Arizona
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Phoenix, Arizona, United States
- Research Site
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Georgia
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Atlanta, Georgia, United States
- Research Site
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Illinois
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Park Ridge, Illinois, United States
- Research Site
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Kentucky
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Louisville, Kentucky, United States
- Research Site
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Louisiana
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Marrero, Louisiana, United States
- Research Site
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Massachusetts
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Newton, Massachusetts, United States
- Research Site
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Michigan
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Southfield, Michigan, United States
- Research Site
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Nevada
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Las Vegas, Nevada, United States
- Research Site
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New York
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Brooklyn, New York, United States
- Research Site
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New York, New York, United States
- Research Site
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Ohio
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Akron, Ohio, United States
- Research Site
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Dayton, Ohio, United States
- Research Site
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Tennessee
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Chattanooga, Tennessee, United States
- Research Site
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Virginia
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Roanoke, Virginia, United States
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations)
- patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams
Exclusion Criteria:
- patients who have used a PPI (proton pump inhibitors; used to reduce the amount of acid in the stomach) within 7 days before enrollment in the open label treatment phase (Day 0)
- patients with a history of acute life-threatening event
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Open Label Esomeprazole
This is an open label, run-in phase.
All patients received Esomeprazole.
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Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
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Experimental: Double Blind Esomeprazole
This is the double blind withdrawal phase.
Patients are randomized to active drug or placebo.
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Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
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Placebo Comparator: Double Blind Placebo
This is the double blind withdrawal phase.
Patients are randomized to active drug or placebo.
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Double Blind Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)
Time Frame: Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
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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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Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants Discontinuing Due to Any Reason, Including Symptom Worsening, in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)
Time Frame: Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
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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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Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
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Treatment Successes at the End of the 4-week Double-blind Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint).
Time Frame: Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
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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 |
Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
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Physician's Global Assessment (PGA) of Gastroesophageal Reflux Disease (GERD) Symptoms (Treatment Withdrawal Phase Endpoint)
Time Frame: Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
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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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Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
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Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)
Time Frame: 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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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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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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Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)
Time Frame: 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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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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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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Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)
Time Frame: 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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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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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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Severity of Feeding Difficulties Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)
Time Frame: 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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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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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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Improvement in Physician's Global Assessment (PGA) Following Open-label Esomeprazole (Open-label Phase Endpoint)
Time Frame: Open-label treatment period (2 weeks)
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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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Open-label treatment period (2 weeks)
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Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Open-label Phase)
Time Frame: Open Label phase (Screening plus two weeks)
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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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Open Label phase (Screening plus two weeks)
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Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Open-label Phase Endpoint)
Time Frame: Open Label Phase (Screening plus two weeks)
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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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Open Label Phase (Screening plus two weeks)
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Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Open-label Phase Endpoint)
Time Frame: Open Label Phase (Screening plus two weeks)
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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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Open Label Phase (Screening plus two weeks)
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Severity of Feeding Difficulties as Reported by Parent/Guardian (Open-label Phase Endpoint)
Time Frame: Open Label Phase (Screening plus two weeks)
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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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Open Label Phase (Screening plus two weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jill McGuinn, AstraZeneca
- Study Director: Marta Ilueca, AstraZeneca
- Study Director: Jennifer Heckman, AstraZeneca
Publications and helpful links
General Publications
- Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the Treatment of GERD in Infants Ages 1-11 Months. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S9-15. doi: 10.1097/MPG.0b013e3182496b35.
- Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the Treatment of GERD in Infants Ages 1-11 Months. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S9-15. doi: 10.1097/MPG.0b013e3182496b35.
- Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the treatment of GERD in infants ages 1-11 months. J Pediatr Gastroenterol Nutr. 2012 Jul;55(1):14-20. doi: 10.1097/MPG.0b013e3182496b35.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D9614C00096
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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