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Rifaximin

Phase 3

Clostridium Infections | Small molecule | Infectious Disease |Bausch Health Companies Inc.|Last Updated: Dec 18, 2019

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment237
FDA Designations
No designations recorded
Clinical trial landscape

Rifaximin · 9 trials · 6 indications

Phase 3 7Phase 2 1Phase 1 1
NCT00724126Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)Non-Constipation Irritable Bowel Syndrome
COMPLETED637 Analytics
NCT00731679Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)Non-Constipation Irritable Bowel Syndrome
COMPLETED623 Analytics
NCT00686920Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic EncephalopathyHepatic Encephalopathy
COMPLETED322 Analytics
NCT00298038A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic EncephalopathyHepatic Encephalopathy
COMPLETED299 Analytics
NCT00269399A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)Clostridium Infections
COMPLETED237 Analytics
NCT00328380Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.Diarrhea
COMPLETED660 Analytics
NCT00742469Rifaximin for Prevention of Travellers' DiarrheaDiarrhea
COMPLETED210 Analytics
PHASE3COMPLETED
Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
Non-Constipation Irritable Bowel SyndromeUnlock trial analytics
PHASE3COMPLETED
Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
Non-Constipation Irritable Bowel SyndromeUnlock trial analytics
PHASE3COMPLETED
Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
Hepatic EncephalopathyUnlock trial analytics
PHASE3COMPLETED
A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy
Hepatic EncephalopathyUnlock trial analytics
PHASE3COMPLETED
A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Clostridium InfectionsUnlock trial analytics
PHASE3COMPLETED
Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.
DiarrheaUnlock trial analytics
PHASE3COMPLETED
Rifaximin for Prevention of Travellers' Diarrhea
DiarrheaUnlock trial analytics
Study Endpoints
Primary Endpoints
Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).
4 weeks

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? \[Yes/No\]"

Number Of Participants Reporting A Non-serious Adverse Event Or A Serious Adverse Event
Baseline up to Month 36

A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Time To The First Breakthrough Overt HE Episode
Baseline up to 6 Months (168 days)

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.

Proportion of Participants Achieving Clinical Success, Where Clinical Success is Defined as Resolution or Improvement of Baseline Signs and Symptoms i.e., Abdominal Pain, Fever, Diarrhea.
14 days

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 primary endpoint in this study is the assessment of safety and tolerability of rifaximin 600 mg QD compared to placebo.
Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment
14 days

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.

The primary objective of this trial is to evaluate the efficacy of a 14-day course of oral rifaximin at 550 mg BID versus placebo in providing adequate relief from Diarrhea-associated IBS (DIBS) symptoms.
Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized.
21 to 38 days (including a 21 day screening period)
Secondary Endpoints
Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6)
4 weeks
Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).
4 weeks
Number Of Participants With Postbaseline Potentially Clinically Significant Laboratory (Hematology and Blood Chemistry) Abnormal Results In ≥5% of Participants
Baseline up to Month 36
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORSubjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
RifaximinEXPERIMENTALSubjects 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 ArmEXPERIMENTALrifaximin 400mg taken 3 times a day
Vancomycin Comparator ArmACTIVE_COMPARATORvancomycin 125mg taken 4 times a day
1ACTIVE_COMPARATORRifaximin
2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
RifaximinDRUG -
PlaceboDRUG -
Rifaximin (Xifaxan)DRUG -
VancomycinDRUG -
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites88

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...

Countries:United StatesCanadaMexico
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