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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01543178 | Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study | PHASE3 | COMPLETED | 2,583 | — | — | Feb 1, 2012 | Jun 1, 2014 | Dec 12, 2017 | 296 | United States, Germany +1 |
Subjects who respond to repeat treatment in both IBS-related abdominal pain and stool consistency. The proportion of patients who responded to repeat treatment during the first double-blind repeat treatment phase is presented. Response is defined as improvement from baseline in abdominal pain AND reduction from baseline in diarrhea.
| Arm | Type | Description |
|---|---|---|
| Rifaximin open-label | EXPERIMENTAL | Subjects will receive open-label rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders will continue into Maintenance Phase 1 (treatment free). Nonresponders will withdraw from the study. Subjects who meet criteria for recurrence in Maintenance Phase 1 enter the double-blind period and are randomized 1:1 to receive rifaximin 550 mg or placebo. |
| Double-blind rifaximin (retreatment) | EXPERIMENTAL | Subjects in this arm receive rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks \[treatment free\]) followed by a second retreatment with rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. |
| Double-blind placebo (retreatment) | PLACEBO_COMPARATOR | Subjects in this arm receive placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks \[treatment free\]) followed by a second retreatment with placebo TID for 2 weeks with a 4-week treatment-free follow-up. |
| Name | Type | Description |
|---|---|---|
| open-label rifaximin | DRUG | 550 mg three times a day (open-label) |
| double-blind placebo | DRUG | 3 times a day (double-blind) |
| double-blind rifaximin | DRUG | 550 mg three times a day (double-blind) |
Inclusion Criteria: * IBS confirmed by Rome III diagnostic criteria. * At least 18 years of age. * Colonoscopy within the past 10 years to rule out inflammatory bowel disease; or flexible sigmoidoscopy if \< 50 years of age or previous colonoscopy \> 10 years prior. * Willing to maintain a stable d...