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rofecoxib

Phase 3

Osteoarthritis | Small molecule | Musculoskeletal |Novartis AG|Last Updated: Mar 18, 2008

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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment309
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00637949Safety of Lumiracoxib in Patients With OsteoarthritisPHASE3 COMPLETED 309Dec 1, 2000Mar 1, 2001Mar 18, 2008 -
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Study Endpoints
Primary Endpoints
Incidence of at least one of seven predefined gastrointestinal adverse events
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
lumiracoxibDEVICE400 mg once daily, oral over 6 weeks
rofecoxibDRUG25 mg, oral, daily over 6 weeks
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Eligibility Criteria
Age Range50 Years — 90 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Age \>=50 years old * Primary osteoarthritis in hip, hand, knee or spine for at least 3 month * Pain in the target joint of moderate intensity * Written informed consent Exclusion Criteria: * Secondary osteoarthritis * Active upper gastro intestinal tract ulceration * Inflam...

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