Status:
COMPLETED
A Study of ABT-652 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 compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to placebo in subjects with osteoarthritis (OA) of the knee.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT01207115
Start Date
September 1 2010
End Date
May 1 2011
Last Update
January 7 2013
Active Locations (38)
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1
Site Reference ID/Investigator# 37220
Chandler, Arizona, United States, 85224
2
Site Reference ID/Investigator# 37223
Tempe, Arizona, United States, 85282
3
Site Reference ID/Investigator# 37215
Tucson, Arizona, United States, 85704
4
Site Reference ID/Investigator# 37221
Anaheim, California, United States, 92801