Clinical trial NCT01451385: Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain
Official title: An Open Label Safety Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Low Back Pain
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2011-10-13
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility 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

Primary outcomes:
measure: Summary of Adverse Events (AEs)
timeFrame: 5 Weeks
Secondary outcomes:
measure: Modified Brief Pain Index - Short Form: Pain Intensity
timeFrame: at end of treatment (within 5 weeks)
measure: Modified Brief Pain Index - Short Form: Percent Pain Relief From Medication
timeFrame: at end of treatment (within 5 weeks)
measure: Modified Brief Pain Inventory-Short Form: Pain Interference Scores
timeFrame: at end of treatment (within 5 weeks)
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Pain Score
timeFrame: End of treatment (within 5 weeks)
measure: WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Stiffness Score
timeFrame: End of treatment (within 5 weeks)
measure: WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Physical Function Score
timeFrame: End of treatment (within 5 weeks)
measure: WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Total Score
timeFrame: End of treatment (within 5 weeks)
measure: Roland-Morris Low Back Pain and Disability Scores for Participants With Chronic Low Back Pain
timeFrame: End of treatment (within 5 weeks)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: Anaheim
country: United States
facility: United Clinical Research Center, Inc.
state: California
city: Buena Park
country: United States
facility: Associated Pharmaceutical Research Center, Inc.
state: California
city: Chino
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Escondido
country: United States
facility: Synergy Escondido Clinical Research
state: California
city: Fresno
country: United States
facility: Convergys Clinical Research, Inc.
state: California
city: La Mesa
country: United States
facility: Triwest Research Associates
state: California
city: Long Beach
country: United States
facility: Skyline Research, Inc.
state: California
city: Boynton Beach
country: United States
facility: Orthopedic Research Institute
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Eastern Research
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Oviedo
country: United States
facility: Compass Research East, LLC
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research LLC
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC
state: Florida
city: Sarasota
country: United States
facility: Sarasota Pain Medicine Research, LLC
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Newnan
country: United States
facility: Better Health Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Chicago Anesthesia Pain Specialists
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Leawood
country: United States
facility: International Clinical Research Institute
state: Kansas
city: Crestview Hills
country: United States
facility: Community Research
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, LLC
state: Kentucky
city: Bingham Farms
country: United States
facility: QUEST Research Institute
state: Michigan
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Hightop Medical Research Center/Hilltop Physicians Inc.
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Altoona
country: United States
facility: Allegheny Pain Management
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Austin
country: United States
facility: Austin Diagnostic Clinic
state: Texas
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Salt Lake City
country: United States
facility: Optimum Clinical Research, Inc.
state: Utah
Study officials:
References: