A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)
A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia
1 other identifier
interventional
338
1 country
46
Brief Summary
The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2010
Shorter than P25 for phase_2
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2010
CompletedFirst Posted
Study publicly available on registry
March 18, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
November 19, 2013
CompletedDecember 24, 2013
November 1, 2013
1.3 years
March 17, 2010
September 17, 2013
November 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Complete Dyspepsia Symptom Relief
The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants.
Up to 8 Weeks (including 7 days prior)
Secondary Outcomes (1)
Rate of Satisfactory Symptom Relief
Up to 8 Weeks (including 7 days prior)
Study Arms (4)
Rabeprazole 10 mg
EXPERIMENTALRabeprazole 20 mg
EXPERIMENTALRabeprazole 40 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
Eligibility Criteria
You may qualify if:
- Participants diagnosed as Functional Dyspepsia according to Rome III criteria.
You may not qualify if:
- Participants with neuropsychiatric disorder.
- Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (46)
Unknown Facility
Nagoya, Aichi-ken, Japan
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Akita, Akita, Japan
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Chikushino-shi, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Gifu, Gifu, Japan
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Maebashi, Gunma, Japan
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Hiroshima, Hiroshima, Japan
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Sapporo, Hokkaido, Japan
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Kobe, Hyōgo, Japan
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Nishinomiya, Hyōgo, Japan
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Tsuchiura, Ibaraki, Japan
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Takamatsu, Kagawa-ken, Japan
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Kagoshima, Kagoshima-ken, Japan
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Yokohama, Kanagawa, Japan
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Kochi, Kochi, Japan
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Kumamoto, Kumamoto, Japan
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Kyoto, Kyoto, Japan
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Sendai, Miyagi, Japan
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Miyazaki, Miyazaki, Japan
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Ōita, Oita Prefecture, Japan
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Yufu, Oita Prefecture, Japan
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Nakagami, Okinawa, Japan
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Hirakata, Osaka, Japan
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Moriguchi, Osaka, Japan
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Osaka, Osaka, Japan
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Suita, Osaka, Japan
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Takatsuki, Osaka, Japan
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Karatsu, Saga-ken, Japan
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Saga, Saga-ken, Japan
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Saitama, Saitama, Japan
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Kusatsu, Shiga, Japan
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Izumo, Shimane, Japan
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Fujieda, Shizuoka, Japan
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Hamamatsu, Shizuoka, Japan
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Shizuoka, Shizuoka, Japan
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Ōtawara, Tochigi, Japan
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Shimotsuga, Tochigi, Japan
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Bunkyo, Tokyo, Japan
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Mitaka, Tokyo, Japan
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Nakano City, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Setagaya City, Tokyo, Japan
Unknown Facility
Shibuya City, Tokyo, Japan
Unknown Facility
Shinagawa, Tokyo, Japan
Unknown Facility
Yamagata, Yamagata, Japan
Related Publications (1)
Iwakiri R, Tominaga K, Furuta K, Inamori M, Furuta T, Masuyama H, Kanke K, Nagahara A, Haruma K, Kinoshita Y, Higuchi K, Takahashi S, Kusano M, Iwakiri K, Kato M, Hongo M, Hiraishi H, Watanabe S, Miwa H, Naito Y, Fujimoto K, Arakawa T. Randomised clinical trial: rabeprazole improves symptoms in patients with functional dyspepsia in Japan. Aliment Pharmacol Ther. 2013 Oct;38(7):729-40. doi: 10.1111/apt.12444. Epub 2013 Aug 20.
PMID: 23957383DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Yoshiumi Okubo, Study Director
- Organization
- Eisai Inc.
Study Officials
- STUDY DIRECTOR
Yoshiumi Okubo
Eisai Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2010
First Posted
March 18, 2010
Study Start
April 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
December 24, 2013
Results First Posted
November 19, 2013
Record last verified: 2013-11