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Sponsors and Collaborators: |
Eisai Inc. Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00165672 |
To investigate esophageal reflux condition in patients with non-erosive gastroesophageal reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week treatment with 5 mg/day or 10 mg/day of E3810.
Condition | Intervention | Phase |
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Non-Erosive Gastroesophageal Reflux Disease |
Drug: RABEPRAZOLE SODIUM |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | A Clinical Pharmacology Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease |
Estimated Enrollment: | 20 |
Study Start Date: | May 2005 |
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>
(1) Patients who have "heartburn" 2 days a week or more during consecutive 3 weeks* prior to pre-observation screening. *If a day of screening and a day of starting observation (date of registration) are different, heartburn must continuously be present during the in-between period. (2) Patients who meet both 1) and 2) below;
(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 this study and give written consent for study entry.
<For the treatment period>
Patients with "heartburn diary" that is completely filled out during 7 days until the treatment period (during the observation period).
If the observation period is 8 days or longer, those with heartburn diary of which entries are fulfilled 80% or more during the observation period.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study.
Japan, Aichi-Prefecture | |
Nagoya, Aichi-Prefecture, Japan, 467-0001 | |
Japan, Fukuoka-Prefecture | |
Yukuhashi, Fukuoka-Prefecture, Japan, 824-0026 | |
Fukuoka, Fukuoka-Prefecture, Japan, 811-0213 | |
Fukuoka, Fukuoka-Prefecture, Japan, 810-0001 | |
Japan, Hiroshima-Prefecture | |
Hiroshima, Hiroshima-Prefecture, Japan, 734-0037 | |
Japan, Osaka-Prefecture | |
Osaka, Osaka-Prefecture, Japan, 530-0012 | |
Osaka, Osaka-Prefecture, Japan, 545-0051 | |
Japan, Saga-Prefecture | |
Saga, Saga-Prefecture, Japan, 849-0937 | |
Japan, Shiga-Prefecture | |
Otsu, Shiga-Prefecture, Japan, 520-2121 | |
Japan, Shimane-Prefecture | |
Izumo, Shimane-Prefecture, Japan, 693-0021 | |
Japan, Tokyo | |
Shinjuku-ku, Tokyo, Japan, 162-0052 | |
Bunkyo-ku, Tokyo, Japan, 113-0022 | |
Japan, Yamaguchi-Prefecture | |
Ube, Yamaguchi-Prefecture, Japan, 755-0046 |
Study Director: | Nobuyuk Sugisaki | Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center |
Study ID Numbers: | E3810-J081-462 |
Study First Received: | September 12, 2005 |
Last Updated: | July 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00165672 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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 |