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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00132496 |
Purpose
The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (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 |
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: | 111 |
| Study Start Date: | August 2005 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 12 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 25 Study Locations| Study Director: | Yufang Lu | Eisai Inc. |
More Information
| Responsible Party: | Eisai Medical Research Inc. ( Yufang Lu, Study Director ) |
| Study ID Numbers: | E3810-A001-202 |
| Study First Received: | August 19, 2005 |
| Results First Received: | August 25, 2009 |
| Last Updated: | November 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00132496 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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GERD |
|
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 |