|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00165841 |
Purpose
The purpose of this study to determine the efficacy of 20 mg of rabeprazole given as a maintenance intermittent therapy following acute treatment for Symptomatic Gastroesophageal Reflux Disease (s-GERD).
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease |
Drug: Rabeprazole 20 mg |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Placebo-Controlled Study of Rabeprazole 20 mg Maintenance Intermittent Therapy Following Acute Treatment in Patients Wth Symptomatic Gastroesophageal Reflux Disease |
| Enrollment: | 200 |
| Study Start Date: | October 2004 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Rabeprazole 20 mg
rabeprazole sodium tablet 20 mg once daily
Other Name: rabeprazole
|
| Experimental: Rabeprazole 20 mg |
Drug: Rabeprazole 20 mg
rabeprazole sodium tablet 20 mg once daily
Other Name: rabeprazole
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Yufang Lu, Study Director, Eisai Medical Research Inc. |
| ClinicalTrials.gov Identifier: | NCT00165841 History of Changes |
| Other Study ID Numbers: | E3810-A001-203 |
| Study First Received: | September 13, 2005 |
| Results First Received: | August 18, 2009 |
| Last Updated: | December 30, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
non-erosive symptomatic GERD GERD |
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Rabeprazole |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |