NCT01207115CompletedPhase 2
A Global Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Osteoarthritis Pain of the Knee
AbbVie (prior sponsor, Abbott)38 sites in 5 countries322 target enrollmentStarted: September 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 322
- Locations
- 38
- Primary Endpoint
- 24-hour average pain score measured by Visual Analog Scale
Study Overview
Brief Summary
To compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to placebo in subjects with osteoarthritis (OA) of the knee.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ABT-652 high dose
Experimental
ABT-652 capsules- twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm.
Intervention: ABT-652 (Drug)
ABT-652 low dose
Experimental
ABT-652 capsules - twice daily for 8 weeks. The dose ABT-652 will depend on the Arm
Intervention: ABT-652 (Drug)
Naproxen
Active Comparator
Naproxen capsules- twice daily for 8 weeks
Intervention: Naproxen (Drug)
Placebo
Placebo Comparator
Placebo capsules- twice daily for 8 weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
24-hour average pain score measured by Visual Analog Scale
Time Frame: 8 weeks
Subject reported pain intensity measured by Visual Analog Scale (0-100)
Secondary Outcomes
- SF-36v2™ Health Status Survey(8 weeks)
- Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores(8 weeks)
- Subject's Global Assessment of Arthritis Status(8 weeks)
- Brief Pain Inventory(8 weeks)
Investigators
Study Sites (38)
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