Osteoarthritis of the Knee
Conditions
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.
Interventions
DRUGABT-652
ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm
DRUGPlacebo
Placebo capsules - twice daily for 8 weeks
DRUGNaproxen
Naproxen capsules - twice daily for 8 weeks
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour average pain score measured by Visual Analog Scale | 8 weeks | Subject reported pain intensity measured by Visual Analog Scale (0-100) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores | 8 weeks | Self administered, patient-centered, health status questionnaire |
| Subject's Global Assessment of Arthritis Status | 8 weeks | Subject reported assessment of arthritis status measured by Visual Analogue Scale (0-100) |
| Brief Pain Inventory | 8 weeks | Subject reported pain intensity and intereference (scale 0-10) |
| SF-36v2™ Health Status Survey | 8 weeks | There is no formal title for this quality of life survey, this is the only name for this measure. Subject reported quality of life survey |
Countries
Australia, Canada, Chile, Puerto Rico, United States
Outcome results
None listed