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doripenum

Phase 3

Urinary Tract Infections | Small molecule | Nephrology |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 Trials1
Total Enrollment741
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00229021Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or PyelonephritisPHASE3 COMPLETED 741Dec 1, 2003Mar 1, 2006Jun 10, 2011 -
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Study Endpoints
Primary Endpoints
Microbiological response measured at test of cure visit at early follow-up.
Secondary Endpoints
Clinical response (cure) assessed at early follow-up visit. Proportion of patients with sustained microbiological and clinical response measured at late follow-up visit. Safety evaluations will be conducted throughout the study.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
doripenumDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosis of complicated lower urinary tract infection or pyelonephritis Exclusion Criteria: * Women who are pregnant, nursing or of child-bearing potential and not using a medically accepted, effective method of birth control * History of moderate or severe hypersensitivity...

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Competitive Landscape -Urinary Tract Infections 5 trials