A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Naproxen

Criteria

Inclusion Criteria

• History of OA of the knee joint and meeting American College of Rheumatology (ACR) Clinical and Radiographic criteria,

• Pain score as required by the protocol at Screening and Baseline

• Willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures.

Exclusion Criteria

• History of sensitivity to histamine medications, acetaminophen (paracetamol), or non-steroidal anti-inflammatory drugs (NSAIDs)

• Active gastrointestinal (GI) disease, GI bleeding or GI ulceration, or history of GI bleeding or GI ulceration in the last 6 months

• History of major psychiatric disorders

• Diagnosis of rheumatoid arthritis, autoimmune disorder, arthritis other than osteoarthritis involving the study joint, or other painful syndrome that could interfere with the assessment of pain at the study joint

• Any cardiac, respiratory, neurological or other medical condition or illness that is not well controlled with treatment