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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
376
COV795 is a multilayer extended-release tablet for oral administration of oxycodone hydrochloride (15 mg) and acetaminophen (650 mg)
Summary of Adverse Events (AEs)
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).
Time frame: 5 Weeks
Modified Brief Pain Index - Short Form: Pain Intensity
Participants rate their pain on a score from 0=no pain to 10=pain as bad as you can imagine
Time frame: at end of treatment (within 5 weeks)
Modified Brief Pain Index - Short Form: Percent Pain Relief From Medication
Participants rate percent pain relief from medication on a scale from 0% (no relief) to 100% (complete relief)
Time frame: at end of treatment (within 5 weeks)
Modified Brief Pain Inventory-Short Form: Pain Interference Scores
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.
Time frame: at end of treatment (within 5 weeks)
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Pain Score
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.
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Genova Clinical Research
Tucson, Arizona, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Orange County Research Institute
Anaheim, California, United States
United Clinical Research Center, Inc.
Anaheim, California, United States
Associated Pharmaceutical Research Center, Inc.
Buena Park, California, United States
Catalina Research Institute, LLC
Chino, California, United States
Synergy Escondido Clinical Research
Escondido, California, United States
Convergys Clinical Research, Inc.
Fresno, California, United States
Triwest Research Associates
La Mesa, California, United States
Skyline Research, Inc.
Long Beach, California, United States
...and 32 more locations
Time frame: End of treatment (within 5 weeks)
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Stiffness Score
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.
Time frame: End of treatment (within 5 weeks)
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Physical Function Score
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.
Time frame: End of treatment (within 5 weeks)
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Total Score
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.
Time frame: End of treatment (within 5 weeks)
Roland-Morris Low Back Pain and Disability Scores for Participants With Chronic Low Back Pain
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.
Time frame: End of treatment (within 5 weeks)