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

An Open Label Safety Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain

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 Overview

• Status: Completed
• Conditions: Osteoarthritis; Low Back Pain
• Intervention / Treatment: Drug: COV795

• Study Type: Interventional
• Enrollment (Actual): 376
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Genova Clinical Research
  • California
    • Anaheim, California, United States, 92804
      • United Clinical Research Center, Inc.
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
    • Anaheim, California, United States, 92801
      • Orange County Research Institute
    • Buena Park, California, United States, 90620
      • Associated Pharmaceutical Research Center, Inc.
    • Chino, California, United States, 91710
      • Catalina Research Institute, LLC
    • Escondido, California, United States, 92025
      • Synergy Escondido Clinical Research
    • Fresno, California, United States, 93726
      • Convergys Clinical Research, Inc.
    • La Mesa, California, United States, 91942
      • TriWest Research Associates
    • Long Beach, California, United States, 90806
      • Skyline Research, Inc.
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Orthopedic Research Institute
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research
    • Hialeah, Florida, United States, 33013
      • Eastern Research
    • North Miami, Florida, United States, 33161
      • Scientific Clinical Research, Inc.
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Orlando, Florida, United States, 32806
      • Clinical Neuroscience Solutions, Inc.
    • Oviedo, Florida, United States, 32765
      • Compass Research East, LLC
    • Plantation, Florida, United States, 33317
      • Gold Coast Research LLC
    • Port Orange, Florida, United States, 32129
      • Accord Clinical Research, LLC
    • Sarasota, Florida, United States, 34238
      • Sarasota Pain Medicine Research, LLC
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Drug Studies America
    • Newnan, Georgia, United States, 30265
      • Better Health Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Chicago Anesthesia Pain Specialists
  • Indiana
    • Evansville, Indiana, United States, 47714
      • MediSphere Medical Research Center, LLC
  • Kansas
    • Leawood, Kansas, United States, 66211
      • International Clinical Research Institute
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Community Research
    • Madisonville, Kentucky, United States, 42431
      • Commonwealth Biomedical Research, LLC
  • Michigan
    • Bingham Farms, Michigan, United States, 48025
      • Quest Research Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
  • New Jersey
    • Trenton, New Jersey, United States, 08540
      • Premier Research
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Community Research
    • Cincinnati, Ohio, United States, 45242
      • New Horizons Clinical Research
    • Cincinnati, Ohio, United States, 45224
      • Hightop Medical Research Center/Hilltop Physicians Inc.
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Allegheny Pain Management
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials
    • Austin, Texas, United States, 78758
      • Austin Diagnostic Clinic
    • Dallas, Texas, United States, 75230
      • KRK Medical Research
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Optimum Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion

1. Be considered in general good health based upon medical and surgical history, vital signs, pulse oximetry, physical exam, clinical lab tests, and electrocardiogram (ECG).
2. Be ≥18 years of age
3. Female subjects are eligible if not pregnant, not lactating or not planning to become pregnant within the next 2 months; surgically sterile or at least 2 years postmenopausal, or practicing an acceptable form of birth control for the duration of the study
4. Male subjects biologically capable of having children must agree to the use of a reliable method of birth control for the duration of the study

5. Have a clinical diagnosis of one of the following:

   • Osteoarthritis (OA) of the knee or hip for at least one year based on the American College of Rheumatology (ACR) criteria
   • Moderate to severe chronic lower back pain (CLBP), i.e. pain that occurs in an area with boundaries between the lowest rib and the crease of the buttocks that 1) must have been present for at least several hours a day for a minimum of 3 months, 2) is not due to a known malignancy, and 3) must be classified as non-neuropathic, neuropathic, or symptomatic for more than 6 months after lower back pain (LBP) surgery based on the Quebec Task Force Classification of Spinal Disorders
6. Have an average in-clinic pain score of ≥3 on the 11-point (0-10) numerical rating scale (NRS) as an average for the last 24 hours at screening visit.
7. Have a pain intensity score of ≥4 on NRS as an average for the last 24 hours at baseline visit.
8. Must, in the investigator's opinion, qualify for opioid therapy for their CLBP or OA.
9. Voluntarily provide written informed consent.

Exclusion

1. Have any clinically significant condition or unstable inter-current illness that would preclude study participation or interfere with the assessment of pain and other symptoms of CLBP or OA or would increase the risk of opioid-related AEs
2. Have an uncontrolled or poorly controlled major psychiatric condition, or have clinically significant anxiety or depression
3. Have an active malignancy or history of malignancy within 2 years
4. Have a history of seizures (except pediatric febrile seizures) or cognitive dysfunction
5. Have clinically significant ECG abnormalities or have uncontrolled hypo- or hypertension
6. Had arthroscopic or open surgery on either knee or hip selected as the primary OA study joint within 6 months
7. For CLBP, had a surgical procedure for back pain within 6 months
8. For CLBP participants, had a nerve or plexus block within 1 month or botulinum toxin injection in the lower back region within 3 months. For participants with OA of the selected primary joint, had joint injection within 1 month prior to Screening Visit 1.
9. Had surgical implants of either the knee or hip selected as the primary OA joint
10. Had gastric reduction surgery
11. Have been taking opioids in equivalents to more than 20 mg oxycodone hydrochloride (OC) or more than 40 mg morphine sulfate (MS) orally per day, or have been taking opioid medications 4 times a week or more
12. Unable to discontinue use of prohibited medications
13. Have a known allergy or hypersensitivity to opioids, OC, acetaminophen (APAP) or ibuprofen.
14. Have abnormal clinical laboratory tests at screening
15. Have a history of substance or alcohol abuse
16. Have positive screening labs for human immunodeficiency virus (HIV), Hepatitis B and/or Hepatitis C
17. Have a positive urine drug test for alcohol, illicit drugs, or controlled substances other than those prescribed medications
18. Have previously participated in a clinical trial using COV795
19. Received any investigational drugs or devices in the past 4 weeks
20. History of spinal stenosis
21. Other criteria as specified in the trial protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COV795; Participants receive 2 tablets of COV795 every 12 hours for up to 35 days	Drug: COV795; COV795 is a multilayer extended-release tablet for oral administration of oxycodone hydrochloride (15 mg) and acetaminophen (650 mg); Other Names: MNK795

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	5 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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.	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.	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.	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.	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.	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.	End of treatment (within 5 weeks)

Collaborators and Investigators

• Sponsor: Mallinckrodt

Study record dates

Study Major Dates

• Study Start: September 20, 2011
• Primary Completion (Actual): June 18, 2012
• Study Completion (Actual): June 18, 2012

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: October 12, 2011
• First Posted (Estimate): October 13, 2011

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Back Pain; Low Back Pain
• Other Study ID Numbers: COV15000181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No