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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00241501 |
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.
Condition | Intervention | Phase |
---|---|---|
Gastroesophageal Reflux Disease (GERD) |
Drug: Esomeprazole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study |
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. |
Estimated Enrollment: | 140 |
Study Start Date: | February 2004 |
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca Nexium Medical Sciences Director, MD | AstraZeneca |
Study ID Numbers: | D9614C00098 |
Study First Received: | October 18, 2005 |
Last Updated: | October 18, 2005 |
ClinicalTrials.gov Identifier: | NCT00241501 |
Health Authority: | United States: Food and Drug Administration |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Omeprazole Esophageal Diseases Gastroesophageal Reflux |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |