Phase 3/Safety & Efficacy of Esomeprazole in Infants
Study identifier:D9614C00096
ClinicalTrials.gov identifier:NCT00468559
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Gastroesophageal reflux disease (GERD)
Phase
Phase 3
Healthy volunteers
No
Study drug
Open Label Run In Esomeprazole, Double Blind Esomeprazole, Double Blind Placebo
Sex
All
Actual Enrollment
98
Study type
Interventional
Age
1 Months - 11 Months
Date
Study Start Date: 01 Apr 2007
Primary Completion Date: 01 Jun 2008
Study Completion Date: 01 Jun 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Marta Ilueca
AstraZeneca
