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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01177410 | Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea | PHASE2 | COMPLETED | 148 | — | — | Jul 1, 2010 | Aug 1, 2011 | Nov 21, 2019 | 20 | United States |
A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Mesalamine Granules 750 mg | EXPERIMENTAL | - |
| Mesalamine Granules 1500 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | placebo capsules once daily for 12 weeks |
| Mesalamine Granules 750 mg | DRUG | 750 mg mesalamine granules once daily for 12 weeks |
| Mesalamine Granules 1500 mg | DRUG | 1500 mg mesalamine granules once daily for 12 weeks |
Inclusion Criteria: Male or non-pregnant, non-lactating female subjects Diagnosed with IBS confirmed by the Rome III criteria Meet the following IBS symptom scores in all categories during the diary eligibility period: * An average daily score of greater than or equal to 3 for abdominal pain * An...