Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.

Official Title
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A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Knee, Pain

Intervention / Treatment
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* Drug: V116517 50-mg tablets
* Drug: V116517 30-mg tablets
* Drug: Naproxen 500-mg capsules
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Subjects with moderate pain due to OA of the knee as their primary pain condition. Subjects with diagnostic criteria for primary pain condition (American college of Rheumatology [ACR] clinical and radiographic criteria): At least 1 of the following in addition to knee pain: age >50, stiffness <30 min, crepitus on active motion, and Kellgren-Lawrence (K-L) grade ≥ 2 radiographic evidence within the past 2 years. Key Exclusion Criteria: Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area. Subjects who cannot or will not agree to stop all concomitant analgesic medications, apart from specified protocol supplemental analgesic medications. Subjects with history of seizures within the past 5 years. Subjects who use opioids more than 4 days per week. Pain-condition-specific exclusions: Subjects who received local pain-control procedures, including intra- articular steroid injection in the study knee or intramuscular steroid injection at any site within 6 weeks of entering the study or hyaluronate injection in the study knee within 12 weeks of entering the study. Subjects who have had arthroscopy on either knee or hip within 6 months of entering the study, or open surgery on either knee or hip within 12 months of entering the study. Active-comparator-related exclusions: Subjects who are allergic to or cannot tolerate naproxen or acetaminophen, including history of NSAID-induced asthma, or nasal polyps; Subjects with history of bleeding disorders or history of documented gastrointestinal ulcer disease. Other protocol specific inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: V116517 - 50 mg<br>V116517 50-mg tablets | Drug: V116517 50-mg tablets<br>* Taken orally twice daily<br>Drug: Placebo<br>* Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily<br>|
| Experimental: V116517 - 30 mg<br>V116517 30-mg tablets | Drug: V116517 30-mg tablets<br>* Taken orally twice daily<br>Drug: Placebo<br>* Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily<br>|
| Active Comparator: Naproxen 500 mg<br>Naproxen 500-mg capsules | Drug: Naproxen 500-mg capsules<br>* Taken orally twice daily<br>Drug: Placebo<br>* Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster OA Index (WOMAC) Pain Score |  | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Physical Function Score |  | Week 4 | 
| WOMAC Stiffness Score |  | Week 4 | 
| Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain |  | Week 4 | 
| Patient Global Impression of Change (PGIC) |  | Week 4 | 
| Supplemental Analgesic Medication Use |  | Over 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Osteoarthritis, Knee