Clinical trial NCT01089543: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Functional Dyspepsia
Keywords: dyspepsia
rabeprazole
Japan
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-18
Enrollment: 338
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Rate of Complete Dyspepsia Symptom Relief
timeFrame: Up to 8 Weeks (including 7 days prior)
Secondary outcomes:
measure: Rate of Satisfactory Symptom Relief
timeFrame: Up to 8 Weeks (including 7 days prior)
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Chikushino
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Maebashi
country: Japan
state: Gunma
city: Sapporo
country: Japan
state: Hokkaido
city: Kobe
country: Japan
state: Hyogo
city: Nishinomiya
country: Japan
state: Hyogo
city: Tsuchiura
country: Japan
state: Ibaraki
city: Takamatsu
country: Japan
state: Kagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Sendai
country: Japan
state: Miyagi
city: Yufu
country: Japan
state: Oita
city: Nakagami
country: Japan
state: Okinawa
city: Hirakata
country: Japan
state: Osaka
city: Moriguchi
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Karatsu
country: Japan
state: Saga
city: Kusatsu
country: Japan
state: Shiga
city: Izumo
country: Japan
state: Shimane
city: Fujieda
country: Japan
state: Shizuoka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Otawara
country: Japan
state: Tochigi
city: Shimotsuga
country: Japan
state: Tochigi
city: Bunkyo
country: Japan
state: Tokyo
city: Mitaka
country: Japan
state: Tokyo
city: Nakano
country: Japan
state: Tokyo
city: Ota
country: Japan
state: Tokyo
city: Setagaya
country: Japan
state: Tokyo
city: Shibuya
country: Japan
state: Tokyo
city: Shinagawa
country: Japan
state: Tokyo
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
Study officials:
affiliation: Eisai Co., Ltd.
name: Yoshiumi Okubo
role: STUDY_DIRECTOR
References:
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.