Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01340053 | A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C) | PHASE2 | COMPLETED | 186 | — | — | May 1, 2011 | Feb 1, 2012 | Oct 15, 2019 | 16 | United States |
Patients complete a phone diary daily. They are asked "how many bowel movements have you had today?" they are then asked for each spontaneous bowel movement (unaided with laxative use) wether there was its was a complete evacuation. if it was then it is a complete spontaneous bowel movement. All CSBMs are added and adjusted for a mean compete sponteneous bowel movement.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Capsule that is identical in size and color to other treatments |
| Low Dose | EXPERIMENTAL | 10 mg capsule of tenapanor |
| Mid Dose | EXPERIMENTAL | 30 mg capsule of tenapanor |
| High Dose | EXPERIMENTAL | 100 mg capsule of tenapanor |
| Name | Type | Description |
|---|---|---|
| RDX5791 | DRUG | Capsule, QD |
Inclusion Criteria: * Subject meets Rome III criteria for IBS-C * If \> 50 years old, colonoscopy evaluation within 10 years * All ages, negative colonoscopy if any "warning symptoms" * Active disease during 2-week screening period * Compliant with IVRS Exclusion Criteria: * Subjects has IBS-D, I...