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 Co., Ltd.338 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

338

Conditions

Functional Dyspepsia

Interventions

RabeprazoleDRUG

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

RabeprazoleDRUG

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

RabeprazoleDRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (46)

Outcomes

Primary Outcomes

Rate of Complete Dyspepsia Symptom Relief

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.

Time frame: Up to 8 Weeks (including 7 days prior)

Secondary Outcomes

Rate of Satisfactory Symptom Relief

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.

Time frame: Up to 8 Weeks (including 7 days prior)

Data from ClinicalTrials.gov

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Nagoya, Aichi-ken, Japan

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Akita, Akita, Japan

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Chikushino-shi, Fukuoka, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Gifu, Gifu, Japan

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Maebashi, Gunma, Japan

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Hiroshima, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Kobe, Hyōgo, Japan

...and 36 more locations