Open Label Safety and Tolerability Study of COV155 in Subjects With Osteoarthritis (OA) or Chronic Low Back Pain (CLBP)
- Conditions
- Osteoarthritis, KneeChronic Low Back PainOsteoarthritis, Hip
- Interventions
- Drug: COV155
- Registration Number
- NCT01722864
- Lead Sponsor
- Mallinckrodt
- Brief Summary
A study to show the safety of COV155 in patients with osteoarthritis of the knee or hip or moderate to severe chronic low back pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description COV155 COV155 COV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 10 to 35 days.
- Primary Outcome Measures
Name Time Method Safety and tolerability of COV155 Up to 35 days Safety evaluations using physical exam, vital signs, clinical laboratory tests, pulse oximetry, and adverse events.
- Secondary Outcome Measures
Name Time Method Modified Brief Pain Inventory short form (mBPI-sf) - pain interference Baseline, Weeks 1, 2, 3, 4, and 5 Evaluate the pain-related quality of life using the Pain Interference subscale of the mBPI-sf.
Modified Brief Pain Inventory short form (mBPI-sf) - intensity Baseline, Weeks 1, 2, 3, 4, and 5 The mean changes from pre-treatment in the worst, least, average, and current pain using the worst, least, average, and current pain intensity items of the mBPI-sf (questions 1 to 4).
Modified Brief Pain Inventory short form (mBPI-sf) - pain relief Baseline, Weeks 1, 2, 3, 4, and 5 Evaluate pain relief using the pain relief item of the mBPI-sf (question 5).
Roland Morris/Disability Questionnaire Baseline, Weeks 1, 2, 3, 4, and 5 The mean changes from pre-treatment in disease-specific quality of life using the Roland Morris LBP and Disability Questionnaire for subjects with CLBP.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Baseline, Weeks 1, 2, 3, 4, and 5 The mean changes from pre-treatment in disease-specific quality of life using the WOMAC (48-hour version) for subjects with OA of the hip or knee.
Trial Locations
- Locations (34)
Probe Clinical Research Corporation - Santa Ana
🇺🇸Santa Ana, California, United States
Martin E. Hale, MD PA (Gold Coast Research LLC)
🇺🇸Plantation, Florida, United States
International Clinical Research, LLC
🇺🇸Sanford, Florida, United States
Pain Specialists of Charleston
🇺🇸North Charleston, South Carolina, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Lake Internal Medicine Associates
🇺🇸Eustis, Florida, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
Beacon Clinical Research, LLC
🇺🇸Brockton, Massachusetts, United States
Eastern Research
🇺🇸Hialeah, Florida, United States
Palm Springs Research Institute
🇺🇸Hialeah, Florida, United States
DeGarmo Institute for Medical Research
🇺🇸Greer, South Carolina, United States
FutureSearch Trials of Neurology, LP
🇺🇸Austin, Texas, United States
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
United Clinical Research Center, Inc.
🇺🇸Anaheim, California, United States
Orange County Research Institute
🇺🇸Anaheim, California, United States
Torrance Clinical Research Inc.
🇺🇸Lomita, California, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Clinical Study Center of Asheville, LLC
🇺🇸Asheville, North Carolina, United States
Wake Research Associates LLC
🇺🇸Raleigh, North Carolina, United States
Charlottesville Medical Research Center, LLC
🇺🇸Charlottesville, Virginia, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
ClinRx Research LLC
🇺🇸Plano, Texas, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Orlando, Florida, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Goldpoint Clinical Research
🇺🇸Indianapolis, Indiana, United States
Independent Clinical Researchers
🇺🇸Las Vegas, Nevada, United States
The Center for Clinical Research LLC
🇺🇸Winston-Salem, North Carolina, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Hightop Physicians Inc./Medical Research Center
🇺🇸Cincinnati, Ohio, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Health Research Institute
🇺🇸Oklahoma City, Oklahoma, United States
Community Research - Anderson
🇺🇸Cincinnati, Ohio, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States