Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee
NCT ID: NCT01688934
Last Updated: 2013-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
230 participants
INTERVENTIONAL
2012-09-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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V116517 - 50 mg
V116517 50-mg tablets
V116517 50-mg tablets
Taken orally twice daily
Placebo
Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
V116517 - 30 mg
V116517 30-mg tablets
V116517 30-mg tablets
Taken orally twice daily
Placebo
Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
Naproxen 500 mg
Naproxen 500-mg capsules
Naproxen 500-mg capsules
Taken orally twice daily
Placebo
Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
Placebo
Placebo
Placebo
Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
Interventions
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V116517 50-mg tablets
Taken orally twice daily
V116517 30-mg tablets
Taken orally twice daily
Naproxen 500-mg capsules
Taken orally twice daily
Placebo
Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
Eligibility Criteria
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Inclusion Criteria
2. 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.
Exclusion Criteria
2. Subjects who cannot or will not agree to stop all concomitant analgesic medications, apart from specified protocol supplemental analgesic medications.
3. Subjects with history of seizures within the past 5 years.
4. Subjects who use opioids more than 4 days per week.
5. 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.
6. 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.
7. 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.
40 Years
80 Years
ALL
No
Sponsors
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Purdue Pharma LP
INDUSTRY
Responsible Party
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Locations
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Genova Clinical Research, Inc.
Tucson, Arizona, United States
Orthopedic Research Institute
Boynton Beach, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Compass Research East, LLC
Oviedo, 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
PMG Research of Charlotte, LLC.
Charlotte, North Carolina, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
LION Research
Norman, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, United States
PMG Research of Bristol
Bristol, Tennessee, United States
Countries
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Other Identifiers
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VND2001
Identifier Type: -
Identifier Source: org_study_id