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The purpose of this study is to evaluate the safety and efficacy of KWA-0711 in Chronic Constipation (CC) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KWA-0711 High dose | Experimental |
| |
| KWA-0711 Low dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KWA-0711 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting and postprandial blood glucose levels | 2 weeks | |
| Change in fasting and postprandial insulin levels | 2 weeks | |
| ECGs, vital signs, and clinical labs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatsuro Takei | Kissei Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30056028 | Derived | Fukudo S, Endo Y, Hongo M, Nakajima A, Abe T, Kobayashi H, Nakata T, Nakajima T, Sameshima K, Kaku K; Mizagliflozin Study Group. Safety and efficacy of the sodium-glucose cotransporter 1 inhibitor mizagliflozin for functional constipation: a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Sep;3(9):603-613. doi: 10.1016/S2468-1253(18)30165-1. Epub 2018 Jul 25. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 11, 2019 | |
| Reset | Dec 31, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 11, 2019 | Dec 31, 2019 |
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| 2 weeks |
| Improvement of signs and symptoms associated with constipation | 2 weeks |