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| Sponsor: | Eisai Inc. |
|---|---|
| Collaborator: |
Eisai Limited |
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00165672 |
Purpose
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 (Pariet (Rabeprazole Sodium)).
| Condition | Intervention | Phase |
|---|---|---|
|
Non-erosive Gastroesophageal Reflux Disease |
Drug: RABEPRAZOLE SODIUM |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Clinical Pharmacology Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease |
| Enrollment: | 26 |
| Study Start Date: | May 2005 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: RABEPRAZOLE SODIUM
rabeprazole sodium 5 mg: once daily orally for 4 weeks
|
| Experimental: 2 |
Drug: RABEPRAZOLE SODIUM
rabeprazole sodium 10 mg: once daily orally for 4 weeks
|
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>
1) The symptom is a burning sensation arising from the stomach or the lower chest.
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 this 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| Japan | |
| Nagoya, Aichi-Prefecture, Japan, 467-0001 | |
| Fukuoka, Fukuoka-Prefecture, Japan, 810-0001 | |
| Fukuoka, Fukuoka-Prefecture, Japan, 811-0213 | |
| Yukuhashi, Fukuoka-Prefecture, Japan, 824-0026 | |
| Hiroshima, Hiroshima-Prefecture, Japan, 734-0037 | |
| Osaka, Osaka-Prefecture, Japan, 530-0012 | |
| Osaka, Osaka-Prefecture, Japan, 545-0051 | |
| Saga, Saga-Prefecture, Japan, 849-0937 | |
| Otsu, Shiga-Prefecture, Japan, 520-2121 | |
| Izumo, Shimane-Prefecture, Japan, 693-0021 | |
| Bunkyo-ku, Tokyo, Japan, 113-0022 | |
| Shinjuku-ku, Tokyo, Japan, 162-0052 | |
| Ube, Yamaguchi-Prefecture, Japan, 755-0046 | |
| Study Director: | Nobuyuki Sugisaki | Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center |
More Information
| Responsible Party: | Nobuyuki Sugisaki, Eisai Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00165672 History of Changes |
| Other Study ID Numbers: | E3810-J081-462 |
| Study First Received: | September 12, 2005 |
| Results First Received: | July 19, 2011 |
| Last Updated: | September 6, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
24-hour esophageal pH monitoring non-erosive gastroesophageal reflux disease NERD proton pump inhibitor rabeprazole |
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Rabeprazole |
Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |