A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia

Study Overview
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Brief Summary
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To examine the safety and efficacy of Z-338 (YM443) after long-term administration in patients with functional dyspepsia, and also to examine the pattern of long-term administration.

Official Title
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A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia

Conditions
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Dyspepsia, Functional Dyspepsia

Intervention / Treatment
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* Drug: YM443


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient showing at least one of the following 4 symptoms from more than 6 months before obtaining consent postprandial fullness early satiation upper abdominal pain upper abdominal discomfort Patient showing at least 2 of the 8 symptoms shown below repeatedly from 3 months before obtaining consent (At least one symptom of either postprandial fullness or early satiation should be included.) Patient showing either postprandial fullness, bloating in the upper abdomen, or early satiation as the major complaint among the 8 symptoms shown below at the time of obtaining consent upper abdominal pain upper abdominal discomfort postprandial fullness bloating in the upper abdomen early satiation nausea vomiting belching Outpatient Exclusion Criteria: Patient showing symptoms of organic disease (reflux esophagitis, erosion, ulceration, esophageal hiatal hernia, bleeding, malignant tumor, Barrett's esophagus) when upper gastrointestinal endoscopy is performed within 24 weeks before obtaining consent Patient showing heartburn within 12 weeks before obtaining consent Patient complicated by irritable bowel syndrome Patient complicated by diabetes mellitus requiring medication Patient complicated by severe anxiety disorder with some problems in interpersonal relationships or social life Patient complicated by depression (including suspected cases) or sleep disturbance

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: YM443<br>* oral<br>* Other names: acotiamide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's global assessment |  | Every week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disappearance rate of symptoms |  | Every week | 
| Laboratory tests, resting |  | At 0, 4, 12, 24, 36, 48 week | 
| 12-lead ECG |  | At 0, 24 and 48 week | 
| Adverse events |  | During treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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YM443, Z-338, Acotiamide, Rome III, Signs and symptoms, digestive