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) - 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.
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).
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)
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
Orange County Research Institute
🇺🇸Anaheim, California, United States
United Clinical Research Center, Inc.
🇺🇸Anaheim, California, United States
Torrance Clinical Research Inc.
🇺🇸Lomita, California, United States
Probe Clinical Research Corporation - Santa Ana
🇺🇸Santa Ana, California, United States
Lake Internal Medicine Associates
🇺🇸Eustis, Florida, United States
Palm Springs Research Institute
🇺🇸Hialeah, Florida, United States
Eastern Research
🇺🇸Hialeah, Florida, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Orlando, Florida, United States
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