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Clinical Trials/NCT01207115
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

Sponsor
AbbVie (prior sponsor, Abbott)
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (38)

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