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

Mallinckrodt

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis; Low Back Pain

Treatments: Drug: COV795

Study type: Interventional

Funder types: Industry

Identifiers

NCT01451385

COV15000181

Details and patient eligibility

About

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).

Enrollment: 376 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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376 participants in 1 patient group

COV795

Experimental group

Description:

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

Treatment:

Drug: COV795