Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain

Phase 3

Completed

Conditions: Low Back Pain
Osteoarthritis

Interventions: Drug: COV795

Registration Number: NCT01451385

Lead Sponsor: Mallinckrodt

Brief Summary: The primary objective is to demonstrate the safety and tolerability of COV795 with up to 35 days use as evaluated by physical exam, vital signs, pulse oximetry, clinical laboratory tests, and other adverse events (AEs).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 376

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COV795	COV795	Participants receive 2 tablets of COV795 every 12 hours for up to 35 days

Primary Outcome Measures

Name	Time	Method
Summary of Adverse Events (AEs)	5 Weeks	Collection of AEs began with subject's signing of the informed consent form, continued throughout the trial, and ended 7 days following the last dose of study drug, or at early termination. Treatment emergent AEs (TEAEs) are AEs that occurred after the first dose of study drug. TEAEs leading to discontinuation include 2 subjects who died (deaths not related to study drug). Clinically significant changes in values from physical exam, vital signs, clinical laboratory tests, and pulse oximetry were included as treatment emergent adverse events (TEAEs).

Secondary Outcome Measures

Name	Time	Method
Modified Brief Pain Index - Short Form: Percent Pain Relief From Medication	at end of treatment (within 5 weeks)	Participants rate percent pain relief from medication on a scale from 0% (no relief) to 100% (complete relief)
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Physical Function Score	End of treatment (within 5 weeks)	Disease-specific quality of life is assessed using the WOMAC questionnaire (48-hour version) for participants with osteoarthritis (OA) of the hip or knee. The WOMAC physical function score ranges from 0 to 68, with higher scores representing worse functional limitations.
Roland-Morris Low Back Pain and Disability Scores for Participants With Chronic Low Back Pain	End of treatment (within 5 weeks)	Roland-Morris Low Back Pain and Disability Scores for participants with chronic low back pain range from 0 to 24, with higher scores representing greater disability.
Modified Brief Pain Inventory-Short Form: Pain Interference Scores	at end of treatment (within 5 weeks)	Participants answer several questions about how much the pain interferes with their quality of life. The answers range from 0 = no interference to 10=completely interferes, and the average score for all the questions is recorded.
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Stiffness Score	End of treatment (within 5 weeks)	Disease-specific quality of life is assessed using the WOMAC questionnaire (48-hour version) for participants with osteoarthritis (OA) of the hip or knee. The WOMAC stiffness score ranges from 0 to 8, with higher scores representing worse stiffness.
Modified Brief Pain Index - Short Form: Pain Intensity	at end of treatment (within 5 weeks)	Participants rate their pain on a score from 0=no pain to 10=pain as bad as you can imagine
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Total Score	End of treatment (within 5 weeks)	Disease-specific quality of life is assessed using the WOMAC questionnaire (48-hour version) for participants with osteoarthritis (OA) of the hip or knee. The WOMAC total score ranges from 0 to 96, with higher scores representing worse pain/disability.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Pain Score	End of treatment (within 5 weeks)	Disease-specific quality of life is assessed using the WOMAC questionnaire (48-hour version) for participants with osteoarthritis (OA) of the hip or knee. The WOMAC pain score ranges from 0 to 20, with higher scores representing worse pain.

Trial Locations

Locations (41): Associated Pharmaceutical Research Center, Inc.
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Buena Park, California, United States
Catalina Research Institute, LLC
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Chino, California, United States
Synergy Escondido Clinical Research
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Escondido, California, United States
Triwest Research Associates
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La Mesa, California, United States
Skyline Research, Inc.
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Long Beach, California, United States
Orthopedic Research Institute
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Boynton Beach, Florida, United States
Scientific Clinical Research, Inc.
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North Miami, Florida, United States
Compass Research East, LLC
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Oviedo, Florida, United States
Accord Clinical Research, LLC
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Port Orange, Florida, United States
MediSphere Medical Research Center, LLC
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Evansville, Indiana, United States
Better Health Clinical Research
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Newnan, Georgia, United States
Commonwealth Biomedical Research, LLC
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Madisonville, Kentucky, United States
QUEST Research Institute
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Bingham Farms, Michigan, United States
Sundance Clinical Research
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Saint Louis, Missouri, United States
Peters Medical Research
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High Point, North Carolina, United States
Allegheny Pain Management
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Altoona, Pennsylvania, United States
Premier Research
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Trenton, New Jersey, United States
Genova Clinical Research
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Tucson, Arizona, United States
International Clinical Research Institute
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Leawood, Kansas, United States
Advanced Clinical Research Institute
🇺🇸
Anaheim, California, United States
Orange County Research Institute
🇺🇸
Anaheim, California, United States
United Clinical Research Center, Inc.
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Anaheim, California, United States
Convergys Clinical Research, Inc.
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Fresno, California, United States
Optimum Clinical Research, Inc.
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Salt Lake City, Utah, United States
Eastern Research
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Hialeah, Florida, United States
Gold Coast Research LLC
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Plantation, Florida, United States
Sarasota Pain Medicine Research, LLC
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Sarasota, Florida, United States
Drug Studies America
🇺🇸
Marietta, Georgia, United States
New Horizons Clinical Research
🇺🇸
Cincinnati, Ohio, United States
Chicago Anesthesia Pain Specialists
🇺🇸
Chicago, Illinois, United States
Community Research
🇺🇸
Cincinnati, Ohio, United States
Hightop Medical Research Center/Hilltop Physicians Inc.
🇺🇸
Cincinnati, Ohio, United States
KRK Medical Research
🇺🇸
Dallas, Texas, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸
Orlando, Florida, United States
Compass Research, LLC
🇺🇸
Orlando, Florida, United States
Stedman Clinical Trials
🇺🇸
Tampa, Florida, United States
Quality Clinical Research
🇺🇸
Omaha, Nebraska, United States
The Center for Clinical Research
🇺🇸
Winston-Salem, North Carolina, United States
FutureSearch Trials
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Austin, Texas, United States
Austin Diagnostic Clinic
🇺🇸
Austin, Texas, United States
Avail Clinical Research
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DeLand, Florida, United States