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CG5503 IR; tapentadol

Phase 3

Osteoarthritis | Small molecule | Musculoskeletal |Johnson & Johnson|Last Updated: Jun 15, 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-BlindUNCONTROLLED
Total Trials1
Total Enrollment669
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00361582A Study to Evaluate the Effectiveness and Safety of Multiple Doses of Tapentadol(CG5503) in Patients Awaiting Joint Replacement SurgeryPHASE3 COMPLETED 669Oct 1, 2006Aug 1, 2007Jun 15, 2011 -
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Study Endpoints
Primary Endpoints
The primary efficacy outcome is the SPID (Sum of Pain Intensity Difference) calculated at 5 days.
Secondary Endpoints
Secondary efficacy outcomes include, among others, the time to the first use of rescue medication, the distribution of responder rates, and the SPID over 2 and 10 days.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CG5503 IR; tapentadolDRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Clinical diagnosis of chronic osteoarthritis of the hip or the knee based on clinical and radiographic (X-Ray) criteria defined by standard accepted guidelines * candidate (qualifies) for primary one-sided total or partial joint replacement surgery due to noninflammatory, end-...

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