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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT01451385
First received: September 29, 2011
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Osteoarthritis
Low Back Pain
Drug: COV795
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Safety Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

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


Secondary Outcome Measures:
  • Modified Brief Pain Index - Short Form [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Mean changes from pre-treatment in average and worst pain, and quality of life for all subjects

  • Western Ontario and McMaster Universities Arthritis [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Mean changes from pre-treatment in disease-specific quality of life for subjects with OA of the hip or knee

  • Roland Morris LBP and Disability Questionnaire [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Mean changes from pre-treatment in disease-specific quality of life for subject with CLBP


Enrollment: 376
Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COV795 Drug: COV795
2 tablets COV795 taken every 12 hours
Other Name: MNK795

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    • 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.

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 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451385

  Show 42 Study Locations
Sponsors and Collaborators
Mallinckrodt
  More Information

No publications provided

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT01451385     History of Changes
Other Study ID Numbers: COV15000181
Study First Received: September 29, 2011
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Rheumatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014