A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study:Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia )
This study has been completed.
Sponsor:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01089543
First received: March 17, 2010
Last updated: November 15, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.
| Condition | Intervention | Phase |
|---|---|---|
|
Functional Dyspepsia |
Drug: Rabeprazole Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia |
Resource links provided by NLM:
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- Resolution rate of dyspeptic symptoms at last visit in treatment period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate of dyspeptic symptoms at last visit in treatment period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 320 |
| Study Start Date: | April 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Rabeprazole
E3810 10 mg tablet: Once daily orally for 8 weeks.
|
| Experimental: 2 |
Drug: Rabeprazole
E3810 20 mg tablet: Once daily orally for 8 weeks.
|
| Experimental: 3 |
Drug: Rabeprazole
E3810 40 mg tablet: Once daily orally for 8 weeks.
|
| Placebo Comparator: 4 |
Drug: Placebo
Matching Placebo Tablet: Once daily orally for 8 weeks.
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria;
Subjects diagnosed as Functional Dyspepsia according to Rome III criteria.
Exclusion criteria;
Subjects with neuropsychiatric disorder.
Subjects diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089543
Locations
| Japan | |
| Nagoya, Aichi, Japan | |
| Chikushino, Fukuoka, Japan | |
| Kitakyushu, Fukuoka, Japan | |
| Maebashi, Gunma, Japan | |
| Sapporo, Hokkaido, Japan | |
| Kobe, Hyogo, Japan | |
| Nishinomiya, Hyogo, Japan | |
| Takamatsu, Kagawa, Japan | |
| Yokohama, Kanagawa, Japan | |
| Sendai, Miyagi, Japan | |
| Yufu, Oita, Japan | |
| Nakagami, Okinawa, Japan | |
| Moriguchi, Osaka, Japan | |
| Suita, Osaka, Japan | |
| Takatsuki, Osaka, Japan | |
| Karatsu, Saga, Japan | |
| Kusatsu, Shiga, Japan | |
| Izumo, Shimane, Japan | |
| Fujieda, Shizuoka, Japan | |
| Hamamatsu, Shizuoka, Japan | |
| Otawara, Tochigi, Japan | |
| Shimotsuga, Tochigi, Japan | |
| Bunkyo, Tokyo, Japan | |
| Mitaka, Tokyo, Japan | |
| Nakano, Tokyo, Japan | |
| Setagaya, Tokyo, Japan | |
| Shinagawa, Tokyo, Japan | |
| Akita, Japan | |
| Fukuoka, Japan | |
| Gifu, Japan | |
| Hiroshima, Japan | |
| Kagoshima, Japan | |
| Kochi, Japan | |
| Kumamoto, Japan | |
| Kyoto, Japan | |
| Miyazaki, Japan | |
| Oita, Japan | |
| Osaka, Japan | |
| Saga, Japan | |
| Yamagata, Japan | |
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
| Study Director: | Masahiro Munesue | Frontier Clinical Development Section. JAC PCU. Eisai Co., Ltd. |
More Information
No publications provided
| Responsible Party: | Eisai Inc. ( Eisai Co., Ltd. ) |
| ClinicalTrials.gov Identifier: | NCT01089543 History of Changes |
| Other Study ID Numbers: | E3810-J081-204 |
| Study First Received: | March 17, 2010 |
| Last Updated: | November 15, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Eisai Inc.:
|
dyspepsia rabeprazole Japan |
Additional relevant MeSH terms:
|
Dyspepsia Gastritis Signs and Symptoms, Digestive Signs and Symptoms Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Stomach Diseases |
Rabeprazole Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013