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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01089543
First received: March 17, 2010
Last updated: November 27, 2013
Last verified: November 2013
  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:
  • Rate of Complete Dyspepsia Symptom Relief [ Time Frame: Up to 8 Weeks (including 7 days prior) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 8 Weeks (including 7 days prior) ] [ Designated as safety issue: No ]
    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.


Enrollment: 338
Study Start Date: April 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rabeprazole 10 mg Drug: Rabeprazole
Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
Other Name: E3810
Experimental: Rabeprazole 20 mg Drug: Rabeprazole
Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
Other Name: E3810
Experimental: Rabeprazole 40 mg Drug: Rabeprazole
Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
Other Name: E3810
Placebo Comparator: Placebo Drug: Placebo
Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
Other Name: E3810

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Tsuchiura, Ibaraki, Japan
Takamatsu, Kagawa, Japan
Yokohama, Kanagawa, Japan
Sendai, Miyagi, Japan
Yufu, Oita, Japan
Nakagami, Okinawa, Japan
Hirakata, Osaka, 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
Ota, Tokyo, Japan
Setagaya, Tokyo, Japan
Shibuya, 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
Saitama, Japan
Shizuoka, Japan
Yamagata, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Yoshiumi Okubo Eisai Co., Ltd.
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: September 17, 2013
Last Updated: November 27, 2013
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
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014