Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee
- Conditions
- Osteoarthritis, KneePain
- Interventions
- Registration Number
- NCT01688934
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
-
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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V116517 - 50 mg V116517 50-mg tablets V116517 50-mg tablets V116517 - 50 mg Placebo V116517 50-mg tablets V116517 - 30 mg V116517 30-mg tablets V116517 30-mg tablets V116517 - 30 mg Placebo V116517 30-mg tablets Naproxen 500 mg Naproxen 500-mg capsules Naproxen 500-mg capsules Naproxen 500 mg Placebo Naproxen 500-mg capsules Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Western Ontario and McMaster OA Index (WOMAC) Pain Score Week 4
- Secondary Outcome Measures
Name Time Method Patient Global Impression of Change (PGIC) Week 4 WOMAC Physical Function Score Week 4 Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain Week 4 WOMAC Stiffness Score Week 4 Supplemental Analgesic Medication Use Over 4 weeks
Trial Locations
- Locations (18)
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Avail Clinical Research, LLC
🇺🇸Deland, Florida, United States
Westside Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Compass Research East, LLC
🇺🇸Oviedo, Florida, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Northwest Indiana Center for Clinical Research
🇺🇸Valparaiso, Indiana, United States
Analgesic Solutions
🇺🇸Natick, Massachusetts, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
PMG Research of Bristol
🇺🇸Bristol, Tennessee, United States
Clinical Research Center of Reading, LLP
🇺🇸Wyomissing, Pennsylvania, United States
LION Research
🇺🇸Norman, Oklahoma, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Orthopedic Research Institute
🇺🇸Boynton Beach, Florida, United States
Genova Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
PMG Research of Raleigh, LLC
🇺🇸Raleigh, North Carolina, United States
PMG Research of Charlotte, LLC.
🇺🇸Charlotte, North Carolina, United States