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Doripenem

Phase 3

Bacterial Infections and Mycoses | Small molecule | Infectious Disease |Johnson & Johnson|Last Updated: Jun 10, 2011

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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment961
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00210938Doripenem in the Treatment of Complicated Intra-Abdominal InfectionsPHASE3 COMPLETED 478 — — Mar 1, 2004Jan 1, 2006Jun 10, 2011 - —
NCT00229060Doripenem in the Treatment of Complicated Intra-Abdominal InfectionsPHASE3 COMPLETED 483 — — Mar 1, 2004Mar 1, 2006Jun 10, 2011 - —
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Study Endpoints
Primary Endpoints
Clinical response rate measured at late follow-up visit.
The clinical response measured at late follow-up visit.
Secondary Endpoints
Clinical response rate measured at early follow-up visit. Microbiological response rate at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory tests results) conducted throughout the study.
The clinical response at early follow-up visit. Microbiological response at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory test results) conducted throughout the study.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
DoripenemDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Has a requirement for surgical intervention within 24 hours of study entry * Requirement of antibacterial therapy in addition to surgical intervention in certain intra-abdominal infections. Exclusion Criteria: * Female patients who are pregnant, nursing, or if of child beari...

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