A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee

Study Overview
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Brief Summary
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To compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to placebo in subjects with osteoarthritis (OA) of the knee.

Official Title
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A Global Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Osteoarthritis Pain of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: ABT-652
* Drug: Placebo
* Drug: Naproxen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-652 high dose<br>ABT-652 capsules- twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm. | Drug: ABT-652<br>* ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm<br>|
| Experimental: ABT-652 low dose<br>ABT-652 capsules - twice daily for 8 weeks. The dose ABT-652 will depend on the Arm | Drug: ABT-652<br>* ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm<br>|
| Active Comparator: Naproxen<br>Naproxen capsules- twice daily for 8 weeks | Drug: Naproxen<br>* Naproxen capsules - twice daily for 8 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo capsules- twice daily for 8 weeks | Drug: Placebo<br>* Placebo capsules - twice daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour average pain score measured by Visual Analog Scale | Subject reported pain intensity measured by Visual Analog Scale (0-100) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores | Self administered, patient-centered, health status questionnaire | 8 weeks | 
| Subject's Global Assessment of Arthritis Status | Subject reported assessment of arthritis status measured by Visual Analogue Scale (0-100) | 8 weeks | 
| Brief Pain Inventory | Subject reported pain intensity and intereference (scale 0-10) | 8 weeks | 
| SF-36v2™ Health Status Survey | 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 | 8 weeks |