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)

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

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

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Drug: Rabeprazole
* Drug: Rabeprazole
* Drug: Rabeprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rabeprazole 10 mg<br> | Drug: Rabeprazole<br>* Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.<br>* Other names: E3810;|
| Experimental: Rabeprazole 20 mg<br> | Drug: Rabeprazole<br>* Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.<br>* Other names: E3810;|
| Experimental: Rabeprazole 40 mg<br> | Drug: Rabeprazole<br>* Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.<br>* Other names: E3810;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.<br>* Other names: E3810;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dyspepsia, rabeprazole, Japan