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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01451385
Recruitment Status : Completed
First Posted : October 13, 2011
Last Update Posted : May 23, 2017
Information provided by (Responsible Party):

Brief Summary:
The primary objective is to demonstrate the safety and tolerability of COV795 with up to 35 days use as evaluated with physical exam, vital signs, pulse oximetry, clinical laboratory tests, and AEs.

Condition or disease Intervention/treatment Phase
Osteoarthritis Low Back Pain Drug: COV795 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Safety Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain
Study Start Date : September 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: COV795 Drug: COV795
2 tablets COV795 taken every 12 hours
Other Name: MNK795

Primary Outcome Measures :
  1. Treatment Adverse Events [ Time Frame: 5 Weeks ]
    Safety evaluations using physical exam, vital signs, clinical laboratory tests, pulse oximetry, and adverse events.

Secondary Outcome Measures :
  1. Modified Brief Pain Index - Short Form [ Time Frame: 5 weeks ]
    Mean changes from pre-treatment in average and worst pain, and quality of life for all subjects

  2. Western Ontario and McMaster Universities Arthritis [ Time Frame: 5 weeks ]
    Mean changes from pre-treatment in disease-specific quality of life for subjects with OA of the hip or knee

  3. Roland Morris LBP and Disability Questionnaire [ Time Frame: 5 weeks ]
    Mean changes from pre-treatment in disease-specific quality of life for subject with CLBP

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  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:

    • OA of the knee or hip for at least one year based on the American College of Rheumatology (ACR) criteria
    • Moderate to severe 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 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.


  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 subjects, had a nerve or plexus block within 1 month or botulinum toxin injection in the lower back region within 3 months. For subjects 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 OC or more than 40 mg 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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01451385

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Sponsors and Collaborators
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Responsible Party: Mallinckrodt Identifier: NCT01451385    
Other Study ID Numbers: COV15000181
First Posted: October 13, 2011    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neurologic Manifestations
Signs and Symptoms