NCT01444365

A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee

A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of ABT-652 as an Add On Therapy in Subjects With Osteoarthritis of the Knee Experiencing Partial Benefit of a Nonsteroidal Anti-Inflammatory Drug

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of the knee.

Detailed description

This is a randomized withdrawal design study, containing a 4 week open-label period followed by a 6 week double-blind period. The total treatment period will be 10 weeks.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	ABT-652 NSAID	ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed
DRUG	Placebo NSAID	Placebo - 2 placebo capsules twice daily NSAID- as prescribed

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-09-30
• Last updated: 2013-05-15

Locations

31 sites across 1 country: United States