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.
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
First received: March 17, 2010
Last updated: November 15, 2012
Last verified: November 2012
The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.
|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:
U.S. FDA Resources
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 ]
|Study Start Date:||April 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
E3810 10 mg tablet: Once daily orally for 8 weeks.
E3810 20 mg tablet: Once daily orally for 8 weeks.
E3810 40 mg tablet: Once daily orally for 8 weeks.
|Placebo Comparator: 4||
Matching Placebo Tablet: Once daily orally for 8 weeks.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089543
|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|
Sponsors and Collaborators
Eisai Co., Ltd.
|Study Director:||Masahiro Munesue||Frontier Clinical Development Section. JAC PCU. Eisai Co., Ltd.|