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)

November 27, 2013 updated by: Eisai Co., Ltd.

A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia

The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

338

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
    • Aichi
      • Nagoya, Aichi, Japan
    • Fukuoka
      • Chikushino, Fukuoka, Japan
      • Kitakyushu, Fukuoka, Japan
    • Gunma
      • Maebashi, Gunma, Japan
    • Hokkaido
      • Sapporo, Hokkaido, Japan
    • Hyogo
      • Kobe, Hyogo, Japan
      • Nishinomiya, Hyogo, Japan
    • Ibaraki
      • Tsuchiura, Ibaraki, Japan
    • Kagawa
      • Takamatsu, Kagawa, Japan
    • Kanagawa
      • Yokohama, Kanagawa, Japan
    • Miyagi
      • Sendai, Miyagi, Japan
    • Oita
      • Yufu, Oita, Japan
    • Okinawa
      • Nakagami, Okinawa, Japan
    • Osaka
      • Hirakata, Osaka, Japan
      • Moriguchi, Osaka, Japan
      • Suita, Osaka, Japan
      • Takatsuki, Osaka, Japan
    • Saga
      • Karatsu, Saga, Japan
    • Shiga
      • Kusatsu, Shiga, Japan
    • Shimane
      • Izumo, Shimane, Japan
    • Shizuoka
      • Fujieda, Shizuoka, Japan
      • Hamamatsu, Shizuoka, Japan
    • Tochigi
      • Otawara, Tochigi, Japan
      • Shimotsuga, Tochigi, Japan
    • Tokyo
      • Bunkyo, Tokyo, Japan
      • Mitaka, Tokyo, Japan
      • Nakano, Tokyo, Japan
      • Ota, Tokyo, Japan
      • Setagaya, Tokyo, Japan
      • Shibuya, Tokyo, Japan
      • Shinagawa, Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
Other Names:
  • E3810
Experimental: Rabeprazole 10 mg
Drug: Rabeprazole
Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
Other Names:
  • E3810
Drug: Rabeprazole
Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
Other Names:
  • E3810
Drug: Rabeprazole
Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
Other Names:
  • E3810
Experimental: Rabeprazole 20 mg
Drug: Rabeprazole
Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
Other Names:
  • E3810
Drug: Rabeprazole
Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
Other Names:
  • E3810
Drug: Rabeprazole
Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
Other Names:
  • E3810
Experimental: Rabeprazole 40 mg
Drug: Rabeprazole
Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
Other Names:
  • E3810
Drug: Rabeprazole
Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
Other Names:
  • E3810
Drug: Rabeprazole
Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
Other Names:
  • E3810

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Complete Dyspepsia Symptom Relief
Time Frame: Up to 8 Weeks (including 7 days prior)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Satisfactory Symptom Relief
Time Frame: Up to 8 Weeks (including 7 days prior)
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.
Up to 8 Weeks (including 7 days prior)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Investigators

  • Study Director: Yoshiumi Okubo, Eisai Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

March 17, 2010

First Posted (Estimate)

March 18, 2010

Study Record Updates

Last Update Posted (Estimate)

December 24, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E3810-J081-204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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