Recent Updates
Recently added Catalysts

Rifaximin

Phase 3

Diarrhea | Small molecule | Gastrointestinal |Bausch Health Companies Inc.|Last Updated: Dec 18, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment870
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00328380Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.PHASE3 COMPLETED 660Dec 1, 2005Sep 1, 2008Nov 25, 20193 United States
NCT00742469Rifaximin for Prevention of Travellers' DiarrheaPHASE3 COMPLETED 210Jun 1, 2005Apr 1, 2007Dec 18, 20191 Mexico
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
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.

Secondary Endpoints
A secondary endpoints of this study include assessment of the differences between the 2 treatment groups based upon the proportion of subjects with TD during the 14-day Treatment Period.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORRifaximin
2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
RifaximinDRUG -
PlaceboDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: 1. Subject is in good health (as determined by medical history) 2. Subject is planning on traveling anywhere outside the US (except Canada) for at least 5 and no more than 14 days 3. Subject is scheduled to depart on their planned trip no later than 14 days and no earlier than 4...

Countries:United StatesMexico
Unlock Eligibility Criteria