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)

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089543
• Other study ID #: E3810-J081-204
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2010
• Last updated: November 27, 2013
• Start date: April 2010
• Est. completion date: August 2011

Study information

• Verified date: November 2013
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

Drug:
• Rabeprazole
Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
• Rabeprazole
Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
• Rabeprazole
Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
• Placebo
Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 8 Weeks (including 7 days prior)	No
Secondary	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.	Up to 8 Weeks (including 7 days prior)	No