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| Sponsor: | Eisai Inc. |
|---|---|
| Collaborator: |
Eisai Limited |
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00165646 |
Purpose
To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study. Primary endpoint is set as complete relief rate of heartburn at the end of evaluation.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Erosive Gastroesophageal Reflux Disease |
Drug: RABEPRAZOLE SODIUM |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Double-Blind, Placebo-Controlled, Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease |
| Enrollment: | 300 |
| Study Start Date: | September 2004 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patients to be included will be outpatients who meet all of the following criteria. No specific gender is asked.
<For the observation period>
2) The symptom tends to appear frequently or is aggravated after eating, when bending a body forward, and/or when pressing on the abdomen.
(3) Patients categorized in "grade M" (discoloring type: minimal change) according to the Los Angeles System (2nd Modification) for Classification of Reflux Esophagitis.
(4) Patients who are 20 years old or older at the time of obtaining consent. (5) Patients who are informed of the objective and details of the study and give written consent for study entry.
<For the treatment period>
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study.
Contacts and Locations
Show 35 Study Locations| Study Director: | Nobuyuki Sugisaki | Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center |
More Information
| Study ID Numbers: | E3810-J081-461 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 27, 2010 |
| ClinicalTrials.gov Identifier: | NCT00165646 History of Changes |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
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 |