Study identifier:D9614C00096
ClinicalTrials.gov identifier:NCT00468559
EudraCT identifier:N/A
CTIS identifier:N/A
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
Gastroesophageal reflux disease (GERD)
Phase 3
No
Open Label Run In Esomeprazole, Double Blind Esomeprazole, Double Blind Placebo
All
98
Interventional
1 Months - 11 Months
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Apr 2014 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.
Location
Location
Lille Cedex, France
Location
Paris, France
Location
Bochum, Germany
Location
Greifswald, Germany
Location
Nurberg, Germany
Location
Potsdam, Germany
Location
Wuppertal, Germany
Location
Bialystok, Poland
Arms | Assigned Interventions |
---|---|
Experimental: Open Label Esomeprazole This is an open label, run-in phase. All patients received Esomeprazole. | Drug: Open Label Run In Esomeprazole Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg) |
Experimental: Double Blind Esomeprazole This is the double blind withdrawal phase. Patients are randomized to active drug or placebo. | Drug: Double Blind Esomeprazole Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg) |
Placebo Comparator: Double Blind Placebo This is the double blind withdrawal phase. Patients are randomized to active drug or placebo. | Drug: Double Blind Placebo Double Blind Placebo |
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