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ABT-652 NSAID

Phase 2

Osteoarthritis of the Knee | Small molecule | Musculoskeletal |AbbVie Inc.|Last Updated: May 15, 2013

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment202
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01444365A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the KneePHASE2 COMPLETED 202Oct 1, 2011Apr 1, 2012May 15, 201331 United States
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Study Endpoints
Primary Endpoints
Subject's Assessment of Arthritis Pain Intensity
6 weeks

Subject reported 24-hour average pain score measured by Visual Analogue Scale

Secondary Endpoints
Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index
6 weeks
Subject's Global Assessment of Arthritis Status
6 weeks
Cognitive Functioning in Patients with Chronic Pain
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABT-652 NSAIDEXPERIMENTALABT-652 capsules -2 ABT-652 capsules twice daily (add-on) NSAID - as prescribed
Placebo NSAIDPLACEBO_COMPARATORPlacebo - 2 placebo capsules twice daily NSAID - as prescribed
Interventions
NameTypeDescription
ABT-652 NSAIDDRUGABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed
Placebo NSAIDDRUGPlacebo - 2 placebo capsules twice daily NSAID- as prescribed
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Eligibility Criteria
Age Range40 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * History of osteoarthritis (OA) of the knee joint and meeting American College of Rheumatology (ACR) Clinical and Radiographic criteria, * Currently taking nonsteroidal anti-inflammatory drugs (NSAIDs) and still experiencing pain as per the protocol requirements. * Willing to w...

Countries:United States
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