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prulifloxacin

Phase 3

Acute Bacterial Gastroenteritis | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Sep 27, 2010

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment268
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00448422Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult TravelersPHASE3 COMPLETED 268Dec 1, 2006Aug 1, 2008Sep 27, 20101 India
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Study Endpoints
Primary Endpoints
Time to Last Unformed Stool (TLUS)
End of Therapy
Secondary Endpoints
Microbiologic eradication rates
End of therapy/study
Clinical cure based on relief of signs and symptoms
End of therapy/study
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALTablet
2PLACEBO_COMPARATORTablet
Interventions
NameTypeDescription
prulifloxacinDRUGTablet
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of acute bacterial gastroenteritis * Traveler from an industrialized country * Capable of giving Informed Consent Exclusion Criteria: * Fever (\>100.3 degrees) * Pregnant or Breast Feeding or Not using adequate birth control * Known or Suspected (co-)Infection with...

Countries:India
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