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Completed

NCT Number: NCT01089543

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)

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

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Key information

Conditions

Functional Dyspepsia Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rabeprazole

Drug

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

Other names: E3810

Placebo

Drug

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

Other names: E3810

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 18, 2010
Registry last updated
Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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