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This trial is to investigate efficacy and safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation. The difference of responder rate between test group (10, 20 and 40mg) and placebo will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Two tablets of YKP10811 placebo are administered orally once a day for 12 weeks. |
|
| YKP10811 10mg | Experimental | Two tablets of YKP10811 5mg are administered orally once a day for 12 weeks. |
|
| YKP10811 20mg | Experimental | One tablet of YKP10811 20mg and one tablet of placebo are administered orally once a day for 12 weeks. |
|
| YKP10811 40mg | Experimental | Two tablets of YKP10811 20mg are administered orally once a day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YKP10811 5mg | Drug |
| ||
| YKP10811 20mg |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal pain intensity & stool frequency responder | an improvement of equl and more than 30% from baseline in the average of the daily worst abdominal pain score and an increase of equal and more than 1 CSBM from baseline | 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| subject global assessment | the degree of symptom relief on abdominal pain, bloating, stool frequency, stool consistency, etc. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyo jin Park, MD.PhD. | Gang Nam Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gang Nam Severance Hospital | Gang Nam Gu | Seoul | 135-720 | South Korea |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000600155 | carbamic acid 3-(4-((4-amino-5-chloro-2-methoxybenzoylamino)methyl)piperidin-1-yl)-1-(4-fluorophenyl)propyl ester |
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|
| YKP10811 placebo | Drug |
|
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |