A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee
NCT ID: NCT03028870
Last Updated: 2019-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
291 participants
INTERVENTIONAL
2017-03-14
2017-11-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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V120083 30 mg
V120083 30-mg capsules taken orally twice daily
V120083
Capsules
Placebo
Capsules to match V120083 and/or naproxen
V120083 60 mg
V120083 60-mg (2 x 30 mg) capsules taken orally twice daily
V120083
Capsules
Placebo
Capsules to match V120083 and/or naproxen
Naproxen
Naproxen 500-mg capsules taken orally twice daily
Naproxen
Capsules
Placebo
Capsules to match V120083 and/or naproxen
Placebo
Capsules to match V120083 and/or naproxen taken orally twice daily
Placebo
Capsules to match V120083 and/or naproxen
Interventions
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V120083
Capsules
Naproxen
Capsules
Placebo
Capsules to match V120083 and/or naproxen
Eligibility Criteria
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Inclusion Criteria
2. 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, morning stiffness \< 30 minutes, crepitus on active motion, and
* Kellgren-Lawrence (K-L) grade 2 or 3 radiographic evidence at the screening visit as determined by a local radiologist or rheumatologist. If a radiograph is not available, one must be taken and the diagnostic criteria must be confirmed before randomization.
3. Subjects whose OA pain of the index knee is not adequately treated prior to the screening visit:
* Subjects must have a self-reported average pain intensity rating of moderate or severe on a verbal rating scale (ie, none, mild, moderate, and severe) over the 7 days prior to the screening visit
4. The subjects must have "average pain over the last 24 hours" scores ≥ 4 and ≤ 9 on an 11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days during the pain assessment period and come in for randomization within 96 hours after the latest qualifying pain score entry
5. Subjects who are willing and able to stop taking any/all analgesic medications, including over-the-counter pain medications, opioids, marijuana, and topical analgesics for OA pain for the duration of the study, with the exception of study-specific rescue medication.
Exclusion Criteria
2. Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout, pseudogout, 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
3. Subjects scheduled for surgical interventions of the disease site or any other major surgery during the study conduct period
4. Subjects with a history of a prior joint replacement of the index knee
5. 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
6. Subjects with a history of significant trauma to a knee, hip or shoulder within the previous year
7. Subjects who have significant pain, other than or more than knee pain, including significant hip, back pain, that may confound the analgesic efficacy assessments of this study.
40 Years
80 Years
ALL
No
Sponsors
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Shionogi
INDUSTRY
Purdue Pharma LP
INDUSTRY
Responsible Party
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Locations
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Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Terence T. Hart, MD
Tuscumbia, Alabama, United States
Providence Clinical Research
North Hollywood, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Artemis Institute for Clinical Research
San Marcos, California, United States
Future Care Solution, LLC
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Sensible Healthcare, LLC
Ocoee, Florida, United States
Omega Research Consultants, LLC
Orlando, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Buynak Clinical Research, P.C.
Valparaiso, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
St. Louis Center for Clinical Research
St Louis, Missouri, United States
St. Louis Clinical Trials, LC
St Louis, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Hassman Research Institute
Berlin, New Jersey, United States
Drug Trials America
Hartsdale, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Medication Management, LLC
Greensboro, North Carolina, United States
Research Institute of the Carolinas of Piedmont Healthcare, PA
Mooresville, North Carolina, United States
Burke Primary Care
Morganton, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Providence Health Partners - Center for Clinical Research
Dayton, Ohio, United States
Omega Medical Research
Warwick, Rhode Island, United States
Mountain View Clinical Research, Inc.
Greer, South Carolina, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VAN2001
Identifier Type: -
Identifier Source: org_study_id
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