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Study is to assess the effectiveness of TC-6499 in the treatment of constipation predominant IBS patients over a 28-day period.
This is a randomized, double blind, placebo controlled study of a maximum of 24 subjects with constipation predominant irritable bowel syndrome (IBS-C). Sixteen subjects will receive active treatment and 8 subjects will receive matching placebo. There will be a 21-day screening phase before 1st study drug administration on Day 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TC-6499 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TC-6499 | Drug | 5mg enteric-coated oral hard gelatin capsule, administered twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in global IBS symptom relief score | Primary efficacy endpoint assessed weekly using patient's response to a global symptom relief question rating their relief of IBS symptoms over the past week compared to before study entry. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly number of spontaneous bowel movements (SBM) | The number of spontaneous bowel movements not associated with rescue medication will be assessed through patient self-reports | 28 days |
| Severity of pain, bloating, degree of straining, and stool consistency |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Mair, MB, ChB | Quotient Bioresearch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical Ltd | Edinburgh | United Kingdom | ||||
| Quotient Clinical Ltd |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Placebo |
| Drug |
placebo as enteric-coated oral hard gelatin capsule, administered twice daily |
|
Severity of pain, bloating, degree of straining, and stool consistency will be assessed through daily patient self-reports |
| 28 days |
| Ruddington |
| United Kingdom |
| D004066 | Digestive System Diseases |