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Lumiracoxib

Phase 3

Knee Osteoarthritis | Small molecule | Musculoskeletal |Novartis AG|Last Updated: May 21, 2012

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 Enrollment1,684
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00367315Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)PHASE3 COMPLETED 1,684 — — Sep 1, 2003 -May 21, 20122 Germany, Switzerland
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Study Endpoints
Primary Endpoints
Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 13 weeks.
Patient's global assessment of disease activity on a 0-100 mm VAS at 13 weeks.
Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score at 13 weeks.
Secondary Endpoints
• Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
LumiracoxibDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Primary osteoarthritis of knee (confirmed by American College of Rheumatology \[ACR\] criteria). * Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy. Exclusion Criteria: * Evidence of active peptic ulceration within 12 months prior to the screening ...

Countries:GermanySwitzerland
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Competitive Landscape -Osteoarthritis 115 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY3PHASE3Eloralintide, Orforglipron, LY3016859 ISA, LY3556050 ISA, LY3526318 ISA
Pacira Biosciences, Inc.PCRX4PHASE3ZILRETTA, Enekinragene Inzadenovec, FX201
Novo Nordisk A/S Sponsored ADR Class BNVO1PHASE3NNC0487-0111
Bioventus, Inc. Class ABVS1PHASE2PTP-001
Enlivex Ltd.ENLV2PHASE1Allocetra, Allocetra-OTS
Smith & Nephew plc Sponsored ADRSNN10 — Undisclosed
Stryker CorporationSYK11NAUndisclosed
Zimmer Biomet Holdings, Inc.ZBH57NAUndisclosed
Merit Medical Systems, Inc.MMSI1NACorticosteroid
Johnson & JohnsonJNJ1NAUndisclosed
Abbott LaboratoriesABT1NAUndisclosed
Enovis CorporationENOV1NAUndisclosed
Teleflex IncorporatedTFX1 — Undisclosed
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