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)

Eisai

Status and phase: Completed; Phase 2

Conditions: Functional Dyspepsia

Treatments: Drug: Placebo; Drug: Rabeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01089543

E3810-J081-204

Details and patient eligibility

About

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

Enrollment: 338 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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338 participants in 4 patient groups, including a placebo group

Rabeprazole 10 mg

Experimental group

Treatment:

Drug: Rabeprazole

Drug: Rabeprazole

Drug: Rabeprazole

Rabeprazole 20 mg

Experimental group

Treatment:

Drug: Rabeprazole

Drug: Rabeprazole

Drug: Rabeprazole

Rabeprazole 40 mg

Experimental group

Treatment:

Drug: Rabeprazole

Drug: Rabeprazole

Drug: Rabeprazole

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo