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The study was terminated due to slow accrual of subjects.
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The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm 1 | Experimental | ONO-2952 Active tablets, every day for 2 weeks |
|
| Placebo Arm | Placebo Comparator | ONO-2952 Matching Placebo every day for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-2952 | Drug | ONO-2952 Active tablets, every day for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity rating during rectal distention by using a numeric pain rating scale | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed through adverse events and clinical laboratory values | 2 weeks |
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Inclusion Criteria:
Female 18-65 years of age (inclusive)
Diagnosed with IBS based on the following criteria (Rome III criteria):
Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ono Pharma USA, Inc. | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Clinical Site | Boston | Massachusetts | 02215 | United States | ||
| St. Louis Clinical Site |
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| Placebo comparator |
| Drug |
ONO-2952 Matching Placebo every day for 2 weeks |
|
| St Louis |
| Missouri |
| 63110 |
| United States |
| Chapel Hill Clinical Site | Chapel Hill | North Carolina | 27599 | United States |
| Oklahoma City Clinical Site | Oklahoma City | Oklahoma | 73160 | United States |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000607300 | ONO-2952 |
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