Status:
COMPLETED
A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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 washout of analgesics and to follow treatment plan, visit schedules and study procedures.
Exclusion
- 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, psychiatric disorder or any other medical condition or illness that is not well controlled with treatment
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT01444365
Start Date
October 1 2011
End Date
April 1 2012
Last Update
May 15 2013
Active Locations (31)
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1
Site Reference ID/Investigator# 61226
Phoenix, Arizona, United States, 85023
2
Site Reference ID/Investigator# 61221
Phoenix, Arizona, United States, 85032
3
Site Reference ID/Investigator# 61241
Tucson, Arizona, United States, 85704
4
Site Reference ID/Investigator# 61257
Anaheim, California, United States, 92801