Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Eisai Medical Research Inc. |
---|---|
Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00132496 |
The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of GERD in children aged 12 to 16 years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement of the symptoms of GERD and to explore the relationship of symptom relief to dose received, based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.
Condition | Intervention | Phase |
---|---|---|
Gastroesophageal Reflux Disease GERD |
Drug: Rabeprazole Sodium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients |
Enrollment: | 140 |
Study Start Date: | August 2005 |
Ages Eligible for Study: | 12 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Yufang Lu | Eisai Medical Research Inc. |
Study ID Numbers: | E3810-A001-202 |
Study First Received: | August 19, 2005 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00132496 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal Disorder |
Gastrointestinal Diseases Esophageal Diseases Gastroesophageal Reflux Rabeprazole |
Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Gastrointestinal Agents Enzyme Inhibitors Gastroesophageal Reflux Pharmacologic Actions Esophageal Motility Disorders |
Deglutition Disorders Digestive System Diseases Therapeutic Uses Anti-Ulcer Agents Esophageal Diseases Rabeprazole |