A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee

Study Overview
=================
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.

Official Title
-----------------
A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of ABT-652 as an Add On Therapy in Subjects With Osteoarthritis of the Knee Experiencing Partial Benefit of a Nonsteroidal Anti-Inflammatory Drug

Conditions
-----------------
Osteoarthritis of the Knee

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-652 NSAID<br>ABT-652 capsules -2 ABT-652 capsules twice daily (add-on) NSAID - as prescribed | Drug: ABT-652 NSAID<br>* ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed<br>|
| Placebo Comparator: Placebo NSAID<br>Placebo - 2 placebo capsules twice daily NSAID - as prescribed | Drug: Placebo NSAID<br>* Placebo - 2 placebo capsules twice daily NSAID- as prescribed<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's Assessment of Arthritis Pain Intensity | Subject reported 24-hour average pain score measured by Visual Analogue Scale | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index | Self administered, patient-centered, health status questionnaire | 6 weeks | 
| Subject's Global Assessment of Arthritis Status | Subject reported pain intensity measured by Visual Analog Scale | 6 weeks | 
| Cognitive Functioning in Patients with Chronic Pain | Subject reported assessment of cognitive functioning | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis of the knee