Study identifier:D9614C00098
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase III, Multicentre, 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 of Age, Inclusive.
Gastroesophageal reflux disease (GERD)
Phase 3
No
Esomeprazole (Nexium)
All
140
Interventional
12 Years - 17 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The treatment period will be up to 8 weeks.
Location
Location
Mount Pearl, Newfoundland, Canada
Location
Halifax, NS, Canada
Location
Hamilton, ON, Canada
Location
Scarborough, ON, Canada
Location
Sudbury, ON, Canada
Location
Oakville, ON, Canada
Location
Parkdale, PE, Canada
Location
TOURS, France
Arms | Assigned Interventions |
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