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 irritable bowel syndrome with diarrhea, irritable bowel syndrome, clostridium infections, sickle cell disease, pharmacokinetic studies, and hepatic encephalopathy. It is developed by Bausch Health Companies Inc. (BHC) and is currently in Phase 2 clinical development.
Low Dose Rifaximin is a small molecule antibiotic that works by inhibiting bacterial RNA synthesis, thereby reducing gut bacterial overgrowth and inflammation. This mechanism is thought to alleviate symptoms in conditions like irritable bowel syndrome and hepatic encephalopathy by modulating the gut microbiome.
Low Dose Rifaximin is developed by Bausch Health Companies Inc., a company traded under the ticker symbol BHC. The drug is currently in Phase 2 clinical trials for multiple indications, including irritable bowel syndrome and sickle cell disease.
Low Dose Rifaximin is in Phase 2 clinical development. It has completed two trials with a total enrollment of 2,583 participants, including a Phase 2 study for diarrhea-associated irritable bowel syndrome and a Phase 3 study for hepatic encephalopathy. The drug is not yet approved and remains investigational.
Low Dose Rifaximin has completed four clinical trials. NCT00269412 was a Phase 2 study in irritable bowel syndrome with 525 participants. NCT00298038 was a Phase 3 study in hepatic encephalopathy with 299 participants. NCT00743912 was a Phase 1 pharmacokinetic study in healthy volunteers, and NCT05098028 was a Phase 2 study in sickle cell disease.
Low Dose Rifaximin is a formulation of rifaximin, an antibiotic. The trials listed under Low Dose Rifaximin include studies of rifaximin at various doses, such as NCT00269412 for irritable bowel syndrome and NCT00298038 for hepatic encephalopathy. The drug is being investigated for multiple conditions.