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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)

NCT01089543 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2013-12-24

Study results available
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Summary

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

Conditions

  • Functional Dyspepsia

Interventions

DRUG

Rabeprazole

Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.

DRUG

Rabeprazole

Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.

DRUG

Rabeprazole

Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.

DRUG

Placebo

Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yoshiumi Okubo · Eisai Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01089543 on ClinicalTrials.gov