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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451385
• Other study ID #: COV15000181
• Status: Completed
• Phase: Phase 3
• Start date: September 20, 2011
• Est. completion date: June 18, 2012

Study information

• Verified date: September 2020
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: June 18, 2012
• Est. primary completion date: June 18, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Osteoarthritis

Intervention

Drug:
• COV795
COV795 is a multilayer extended-release tablet for oral administration of oxycodone hydrochloride (15 mg) and acetaminophen (650 mg)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)