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GT160-246

Phase 2

Clostridium Difficile-Associated Diarrhea | Small molecule | Infectious Disease |Sanofi|Last Updated: Mar 5, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00034294A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated DiarrheaPHASE2 COMPLETED 300Feb 1, 2002Jul 1, 2003Mar 5, 201599 United States, Canada +2
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
GT160-246DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites99

Inclusion Criteria: * Be at least 18 years old. * Have active mild to moderate C. difficile- Associated Diarrhea (CDAD). * Be able to tolerate oral medication. * Not be pregnant or breast-feeding. * Sign and date an informed consent form.

Countries:United StatesCanadaPuerto RicoUnited Kingdom
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