Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain
Condition: Osteoarthritis; Low Back Pain
MeSH terms: Osteoarthritis; Back Pain; Low Back Pain
Intervention: COV795
Intervention description: COV795 is a multilayer extended-release tablet for oral administration of oxycodone hydrochloride (15 mg) and acetaminophen (650 mg)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 376.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        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