Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain
NCT ID: NCT01451385
Last Updated: 2020-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
376 participants
INTERVENTIONAL
2011-09-20
2012-06-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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COV795
Participants receive 2 tablets of COV795 every 12 hours for up to 35 days
COV795
COV795 is a multilayer extended-release tablet for oral administration of oxycodone hydrochloride (15 mg) and acetaminophen (650 mg)
Interventions
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COV795
COV795 is a multilayer extended-release tablet for oral administration of oxycodone hydrochloride (15 mg) and acetaminophen (650 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Locations
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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
Orthopedic Research Institute
Boynton Beach, Florida, United States
Avail Clinical Research
DeLand, Florida, United States
Eastern Research
Hialeah, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, 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
Sarasota Pain Medicine Research, LLC
Sarasota, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Drug Studies America
Marietta, Georgia, United States
Better Health Clinical Research
Newnan, Georgia, United States
Chicago Anesthesia Pain Specialists
Chicago, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
International Clinical Research Institute
Leawood, Kansas, United States
Community Research
Crestview Hills, Kentucky, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States
QUEST Research Institute
Bingham Farms, Michigan, United States
Sundance Clinical Research
St Louis, Missouri, United States
Quality Clinical Research
Omaha, Nebraska, United States
Premier Research
Trenton, New Jersey, United States
Peters Medical Research
High Point, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Hightop Medical Research Center/Hilltop Physicians Inc.
Cincinnati, Ohio, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Allegheny Pain Management
Altoona, Pennsylvania, United States
FutureSearch Trials
Austin, Texas, United States
Austin Diagnostic Clinic
Austin, Texas, United States
KRK Medical Research
Dallas, Texas, United States
Optimum Clinical Research, Inc.
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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COV15000181
Identifier Type: -
Identifier Source: org_study_id
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