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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Z-338 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Z-338 | Drug | Oral |
| |
| Placebo |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Individual symptom score | Every week | |
| SF-NDI | At 0, 4 week and 4 week after treatment | |
| General Impression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michio Hongo, Professor | Tohoku University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hokkaido | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22157329 | Derived | Matsueda K, Hongo M, Tack J, Saito Y, Kato H. A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia. Gut. 2012 Jun;61(6):821-8. doi: 10.1136/gutjnl-2011-301454. Epub 2011 Dec 9. |
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| ID | Term |
|---|---|
| C410959 | Z 338 |
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| Drug |
Oral |
|
| Every week |
| Laboratory tests | At 0, 4 week and 4 week after treatment |
| Adverse Event | 4 week treatment period and 4 week after treatment |
| Tokyo |
| Japan |