Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
open-label rifaximin · 1 trial · 1 indication
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...
Low Dose Rifaximin is an investigational small molecule being studied for gastrointestinal conditions including non-constipation irritable bowel syndrome, diarrhea, irritable bowel syndrome with diarrhea, and Clostridium infections. It is developed by Bausch Health Companies Inc. (BHC) and is currently in Phase 2 clinical development.
Low Dose Rifaximin is a rifamycin antibiotic that works by inhibiting bacterial RNA synthesis, thereby reducing intestinal bacterial overgrowth and altering the gut microbiome. This mechanism is thought to alleviate symptoms of irritable bowel syndrome with diarrhea and other gastrointestinal disorders.
Low Dose Rifaximin is being developed by Bausch Health Companies Inc., a company traded on the New York Stock Exchange under the ticker symbol BHC. The drug is currently in Phase 2 clinical trials for gastrointestinal indications.
Low Dose Rifaximin is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing to evaluate its safety and efficacy for conditions such as irritable bowel syndrome with diarrhea.
Low Dose Rifaximin has completed four Phase 3 trials, including NCT00269399 comparing it to vancomycin for Clostridium difficile-associated diarrhea, NCT00328380 and NCT00742469 for prevention of travelers' diarrhea, and NCT01543178 for irritable bowel syndrome with diarrhea re-treatment. These trials enrolled a total of 2,583 participants.
Low Dose Rifaximin is a formulation of rifaximin, the active ingredient in Xifaxan. The clinical trial NCT00269399 compared Xifaxan to vancomycin for Clostridium difficile-associated diarrhea, indicating that Low Dose Rifaximin is related to the Xifaxan brand.