A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-981 in Patients With Osteoarthritis of the Knee
Sponsored by AbbVie (prior sponsor, Abbott)
About this trial
Last updated 8 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 12 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Adult male or female, 40 to 70 years of age, inclusive.
- History of symptomatic osteoarthritis (OA) of the knee joint for at least 3 months, with typical Osteoarthritis (OA) symptoms
- Radiographic Osteoarthritis (OA) of Kellgren-Lawrence (K-L) grade 1, 2 or 3
- Patients assessment of Osteoarthritis (OA) pain intensity of the study joint is between 40 and 80 on the 0 - 100 mm VAS scale
- Other than Osteoarthritis (OA) of the study joint, patient should be in general good health
Exclusion Criteria
- Radiographic OA of Kellgren-Lawrence grade 4 or chronic opioid user due to severe knee OA
- History of allergic reaction or significant sensitivity to any constituents of the study drug and acetominophen or history of anaphylactic reaction to any agent
- Significant trauma or surgery to the study joint within the last year or arthroscopy within 6 months, or, scheduled for major surgery to the study joint
- Diagnosis of rheumatoid arthritis, other autoimmune disorders or any arthritis other than Osteoarthritis (OA) of the knee.
- Any uncontrolled medical illness including unstable treatment or therapy.