Trials / Completed
CompletedNCT00241501
Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
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.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 140 (planned)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Esomeprazole (Nexium) |
Timeline
- Start date
- 2004-02-01
- Completion
- 2005-04-01
- First posted
- 2005-10-19
- Last updated
- 2010-11-19
Locations
40 sites across 4 countries: United States, Canada, France, Italy
Source: ClinicalTrials.gov record NCT00241501. Inclusion in this directory is not an endorsement.