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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)

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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

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

Trial contacts and locations

46

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Data sourced from clinicaltrials.gov

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