Back to resultsA Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)
Primary Purpose
Functional Dyspepsia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Rabeprazole
Rabeprazole
Rabeprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia focused on measuring dyspepsia, rabeprazole, Japan
Eligibility Criteria
Inclusion criteria:
-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.
Exclusion criteria:
- Participants with neuropsychiatric disorder.
- Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Rabeprazole 10 mg
Rabeprazole 20 mg
Rabeprazole 40 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rate of Satisfactory Symptom Relief
The rate of satisfactory symptom relief according to the DSQ defined as scores of <= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of <= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered "yes" or "no" when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01089543
Brief Title
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)
Official Title
A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
dyspepsia, rabeprazole, Japan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
338 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rabeprazole 10 mg
Arm Type
Experimental
Arm Title
Rabeprazole 20 mg
Arm Type
Experimental
Arm Title
Rabeprazole 40 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rabeprazole
Other Intervention Name(s)
E3810
Intervention Description
Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Rabeprazole
Other Intervention Name(s)
E3810
Intervention Description
Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Rabeprazole
Other Intervention Name(s)
E3810
Intervention Description
Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
E3810
Intervention Description
Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
Primary Outcome Measure Information:
Title
Rate of Complete Dyspepsia Symptom Relief
Description
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.
Time Frame
Up to 8 Weeks (including 7 days prior)
Secondary Outcome Measure Information:
Title
Rate of Satisfactory Symptom Relief
Description
The rate of satisfactory symptom relief according to the DSQ defined as scores of <= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of <= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered "yes" or "no" when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants.
Time Frame
Up to 8 Weeks (including 7 days prior)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.
Exclusion criteria:
Participants with neuropsychiatric disorder.
Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshiumi Okubo
Organizational Affiliation
Eisai Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Nagoya
State/Province
Aichi
Country
Japan
City
Chikushino
State/Province
Fukuoka
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
City
Maebashi
State/Province
Gunma
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Kobe
State/Province
Hyogo
Country
Japan
City
Nishinomiya
State/Province
Hyogo
Country
Japan
City
Tsuchiura
State/Province
Ibaraki
Country
Japan
City
Takamatsu
State/Province
Kagawa
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Sendai
State/Province
Miyagi
Country
Japan
City
Yufu
State/Province
Oita
Country
Japan
City
Nakagami
State/Province
Okinawa
Country
Japan
City
Hirakata
State/Province
Osaka
Country
Japan
City
Moriguchi
State/Province
Osaka
Country
Japan
City
Suita
State/Province
Osaka
Country
Japan
City
Takatsuki
State/Province
Osaka
Country
Japan
City
Karatsu
State/Province
Saga
Country
Japan
City
Kusatsu
State/Province
Shiga
Country
Japan
City
Izumo
State/Province
Shimane
Country
Japan
City
Fujieda
State/Province
Shizuoka
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
City
Otawara
State/Province
Tochigi
Country
Japan
City
Shimotsuga
State/Province
Tochigi
Country
Japan
City
Bunkyo
State/Province
Tokyo
Country
Japan
City
Mitaka
State/Province
Tokyo
Country
Japan
City
Nakano
State/Province
Tokyo
Country
Japan
City
Ota
State/Province
Tokyo
Country
Japan
City
Setagaya
State/Province
Tokyo
Country
Japan
City
Shibuya
State/Province
Tokyo
Country
Japan
City
Shinagawa
State/Province
Tokyo
Country
Japan
City
Akita
Country
Japan
City
Fukuoka
Country
Japan
City
Gifu
Country
Japan
City
Hiroshima
Country
Japan
City
Kagoshima
Country
Japan
City
Kochi
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Miyazaki
Country
Japan
City
Oita
Country
Japan
City
Osaka
Country
Japan
City
Saga
Country
Japan
City
Saitama
Country
Japan
City
Shizuoka
Country
Japan
City
Yamagata
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
23957383
Citation
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.
Results Reference
derived
Learn more about this trial
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)
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