Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rifaximin · 9 trials · 6 indications
The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of global IBS symptoms was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? \[Yes/No\]"
A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time to a breakthrough overt HE episode was the duration (number of days) from time of first dose of study drug to the first breakthrough overt HE episode. A breakthrough overt HE episode was defined as an increase of Conn score from Grade 0 or 1 to ≥2, or an increase in Conn and asterixis score of 1 grade each for those participants who entered the study with a Conn score of 0. Participants who completed the study and did not experience a breakthrough overt HE episode were censored at the time of their 6-month visit. Participants who terminated early for reasons other than a breakthrough overt HE episode were contacted at 6 months from randomization to determine if they had experienced a breakthrough overt HE event or other outcome. Participants without breakthrough overt HE were censored at the time of last contact or death, whichever was earlier. The number of events of a first breakthrough overt HE episode during the treatment interval is presented.
Resolution or improvement of baseline signs and symptoms was assessed as * Absence of severe abdominal pain for 2 consecutive days at the test of cure (TOC) Visit (Day 14 +/-1); * Absence of fever (\< 38°C/100.4°F) for 2 consecutive days at the TOC Visit; and * 3 unformed (loose or watery) stools per day for at least 48 hours that was sustained through the TOC Visit.
The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period. |
| Rifaximin | EXPERIMENTAL | Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period. |
| Rifaximin Treatment Arm | EXPERIMENTAL | rifaximin 400mg taken 3 times a day |
| Vancomycin Comparator Arm | ACTIVE_COMPARATOR | vancomycin 125mg taken 4 times a day |
| 1 | ACTIVE_COMPARATOR | Rifaximin |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Rifaximin | DRUG | - |
| Placebo | DRUG | - |
| Rifaximin (Xifaxan) | DRUG | - |
| Vancomycin | DRUG | - |
Inclusion Criteria: * Confirmed IBS diagnosis per Rome II criteria for diagnosis of IBS. * Colonoscopy within 2 years as part of IBS diagnostic evaluation. * Has active symptoms of non-constipation IBS at baseline as measured by average daily scores for abdominal pain/discomfort, bloating, and stoo...
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.