A Study to Evaluate the Analgesic Efficacy and Safety of VM902A in Subjects With Osteoarthritis (OA) of the Knee
NCT ID: NCT02847702
Last Updated: 2017-11-22
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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TERMINATED
PHASE2
75 participants
INTERVENTIONAL
2016-08-31
2016-11-22
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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VM902A 200 mg
VM902A 200-mg Capsules
VM902A 200-mg Capsules
Taken orally with food twice daily
Placebo
Capsules to match VM902A and/or naproxen taken orally with food twice daily
VM902A 400 mg
VM902A 400-mg Capsules (2 x 200-mg capsules)
VM902A 400-mg Capsules
Taken orally with food twice daily
Placebo
Capsules to match VM902A and/or naproxen taken orally with food twice daily
Naproxen
Naproxen 500-mg Capsules
Naproxen 500-mg Capsules
Taken orally with food twice daily
Placebo
Capsules to match VM902A and/or naproxen taken orally with food twice daily
Placebo
Placebo
Placebo
Capsules to match VM902A and/or naproxen taken orally with food twice daily
Interventions
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VM902A 200-mg Capsules
Taken orally with food twice daily
VM902A 400-mg Capsules
Taken orally with food twice daily
Naproxen 500-mg Capsules
Taken orally with food twice daily
Placebo
Capsules to match VM902A and/or naproxen taken orally with food twice daily
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, stiffness \< 30 min, 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. Note that K-L grades 2 to 3 require the presence of osteophytes, which is required to meet ACR clinical and radiographic criteria for knee OA
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 ≥ 5 and ≤ 9 on an 11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days during the screening period and come in for randomization within 72 hours after qualification is met
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 treatment period, with the exception of study-specific rescue medication.
Exclusion Criteria
2. Subjects at risk for destructive arthropathy, subjects with a history of osteonecrosis, osteoporotic fracture, rapidly progressive osteoarthritis (RPOA 1 and 2), subchondral insufficiency fracture, and hip/knee dislocations
3. Subjects considered high risk for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required
4. Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout (except for subjects with gout that is controlled with diet and/or with stable suppressive treatment with uric acid reducing medication(s) and/or colchicine, and who have not had any attack within the past 2 years), 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
5. Subjects scheduled for surgical interventions of the disease site or any other major surgery during the study conduct period
6. Subjects with a history of a prior joint replacement of the index knee
7. 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.
40 Years
75 Years
ALL
No
Sponsors
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Purdue Pharma LP
INDUSTRY
Responsible Party
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Locations
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Investigational Site
Birmingham, Alabama, United States
Investigational Site
Huntsville, Alabama, United States
Investigational Site
DeLand, Florida, United States
Investigational Site
Hialeah, Florida, United States
Investigational Site
Homestead, Florida, United States
Investigational Site
Jupiter, Florida, United States
Investigational Site
Orlando, Florida, United States
Investigational Site
Port Orange, Florida, United States
Investigational Site
Port Saint Lucie, Florida, United States
Investigational Site
The Villages, Florida, United States
Investigational Site
West Palm Beach, Florida, United States
Investigational Site
Columbus, Georgia, United States
Investigational Site
Avon, Indiana, United States
Investigational Site
Muncie, Indiana, United States
Investigational Site
Newton, Kansas, United States
Investigational Site
Prairie Village, Kansas, United States
Investigational Site
New Bedford, Massachusetts, United States
Investigational Site
Bay City, Michigan, United States
Investigational Site
Troy, Michigan, United States
Investigational Site
Kansas City, Missouri, United States
Investigational Site
St Louis, Missouri, United States
Investigational Site
Hartsdale, New York, United States
Investigational Site
Rosedale, New York, United States
Investigational Site
The Bronx, New York, United States
Investigational Site
Cincinnati, Ohio, United States
Investigational Site
Dayton, Ohio, United States
Investigational Site
Dublin, Ohio, United States
Investigational Site
Duncansville, Pennsylvania, United States
Investigational Site
Ogden, Utah, United States
Investigational Site
Salt Lake City, Utah, United States
Investigational Site
South Jordan, Utah, United States
Countries
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Other Identifiers
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TKA2001
Identifier Type: -
Identifier Source: org_study_id