Safety of daily dose esomeprazole for GERD for pediatric and adolescent patients
Study identifier:D9614C00098
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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.
Medical condition
Gastroesophageal reflux disease (GERD)
Phase
Phase 3
Healthy volunteers
No
Study drug
Esomeprazole (Nexium)
Sex
All
Actual Enrollment
140
Study type
Interventional
Age
12 Years - 17 Years
Date
Study Start Date: 01 Feb 2004
Primary Completion Date: -
Study Completion Date: 01 Apr 2005
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|
Contacts
Investigators
Principal Investigator
AstraZeneca Nexium Medical Sciences Director
AstraZeneca
