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| Sponsor: | Eisai Co., Ltd. |
|---|---|
| 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 (Pariet (Rabeprazole Sodium)) in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-erosive Gastroesophageal Reflux Disease |
Drug: E3810 Drug: Placebo |
Phase III |
| 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, Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease |
| Enrollment: | 288 |
| Study Start Date: | September 2004 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: E3810
E3810 5mg: once daily orally for 4 weeks
|
| Experimental: 2 |
Drug: E3810
E3810 10mg: once daily orally for 4 weeks
|
| Placebo Comparator: 3 |
Drug: Placebo
Placebo: 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>
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| Japan | |
| Aichi-Gun, Aichi-Prefecture, Japan, 480-1103 | |
| Nagoya, Aichi-Prefecture, Japan, 467-0001 | |
| Nagoya, Aichi-Prefecture, Japan, 466-0065 | |
| Chikushino, Fukuoka-Prefecture, Japan, 818-0024 | |
| Chikushino, Fukuoka-Prefecture, Japan, 818-0067 | |
| Fukuoka, Fukuoka-Prefecture, Japan, 813-0003 | |
| Kita-kyushu, Fukuoka-Prefecture, Japan, 807-1262 | |
| Maebashi, Gunma-Prefecture, Japan, 371-0034 | |
| Hiroshima, Hiroshima-Prefecture, Japan, 730-0052 | |
| Hiroshima, Hiroshima-Prefecture, Japan, 734-0037 | |
| Sapporo, Hokkaido-Prefecture, Japan, 060-0061 | |
| Sapporo, Hokkaido-Prefecture, Japan, 003-0021 | |
| Sapporo, Hokkaido-Prefecture, Japan, 060-0814 | |
| Kochi, Kochi-Prefecture, Japan, 780-0901 | |
| Kyoto, Kyoto-Prefecture, Japan, 602-0000 | |
| Kyoto, Kyoto-Prefecture, Japan, 606-8397 | |
| Sandai, Miyagi-Prefecture, Japan, 980-0872 | |
| Sendai, Miyagi-Prefecture, Japan, 984-0075 | |
| Moriguchi, Osaka-Prefecture, Japan, 570-0021 | |
| Osaka, Osaka-Prefecture, Japan, 530-0012 | |
| Osaka, Osaka-Prefecture, Japan, 545-0051 | |
| Osaka, Osaka-Prefecture, Japan, 536-0002 | |
| Saga, Saga-Prefecture, Japan, 849-0937 | |
| Kawaguchi, Saitama-Prefecture, Japan, 332-0021 | |
| Izumo, Shimane-Prefecture, Japan, 693-0021 | |
| Matsue, Shimane-Prefecture, Japan, 690-0886 | |
| Hamamatsu, Shizuoka-Prefecture, Japan, 431-3125 | |
| Shinagawa-ku, Tokyo, Japan, 140-0011 | |
| Shinjuku-ku, Tokyo, Japan, 162-0052 | |
| Sanyoonoda, Yamaguchi-Prefecture, Japan, 757-0002 | |
| Sanyoonoda, Yamaguchi-Prefecture, Japan, 756-0076 | |
| Ube, Yamaguchi-Prefecture, Japan, 755-0067 | |
| Ube, Yamaguchi-Prefecture, Japan, 755-0077 | |
| Ube, Yamaguchi-Prefecture, Japan, 755-0004 | |
| 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: | NCT00165646 History of Changes |
| Other Study ID Numbers: | E3810-J081-461 |
| Study First Received: | September 12, 2005 |
| Results First Received: | May 23, 2011 |
| Last Updated: | July 14, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
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 |