To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia

Study Overview
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Brief Summary
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The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms.

Official Title
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To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Drug: Z-338
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects showing at least one of the 4 symptoms (upper abdominal pain, upper abdominal discomfort, epigastric pain, epigastric burning) for at least 6 months before obtaining informed consent Subjects showing two or more of the following symptoms: upper abdominal pain, upper abdominal discomfort, post-prandial fullness, upper abdominal bloating, early satiety, nausea, vomiting and/or excessive belching for at least 3 months (one of them should be post-prandial fullness or early satiation) Bothersome symptoms should be post-prandial fullness, upper abdominal bloating or early satiety at the time of obtaining informed consent Exclusion Criteria: Subjects with structural disease that is likely to explain the symptom (e.g., GERD, erosion, ulcer, hiatal hernia, bleeding, malignancy or Barrett's esophagus) confirmed by upper endoscopy at the obtaining informed consent Subjects have heartburn in last 12 weeks before obtaining informed consent Subjects with irritable bowel disease (IBS) Subjects with diabetes mellitus requiring treatment Subjects with serious anxiety disorder Subjects with depression and/or sleep disorder Subjects with biliary tract disease and/or pancreatitis (including chronic pancreatitis)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Z-338<br> | Drug: Z-338<br>* Oral<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General impression at last visit in treatment period |  | 4 week | 
| Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period |  | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual symptom score |  | Every week | 
| SF-NDI |  | At 0, 4 week and 4 week after treatment | 
| General Impression |  | Every week | 
| Laboratory tests |  | At 0, 4 week and 4 week after treatment | 
| Adverse Event |  | 4 week treatment period and 4 week after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acotiamide