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

NCT01451385 | Completed Phase 3 Results FDA Drug

• 1 other identifier: COV15000181
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 42

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).

Conditions

Osteoarthritis; Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Modified Brief Pain Index - Short Form: Pain Intensity

  at end of treatment (within 5 weeks)

• Modified Brief Pain Index - Short Form: Percent Pain Relief From Medication

  at end of treatment (within 5 weeks)

• Modified Brief Pain Inventory-Short Form: Pain Interference Scores

  at end of treatment (within 5 weeks)

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Pain Score

  End of treatment (within 5 weeks)

• WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Stiffness Score

  End of treatment (within 5 weeks)

Study Arms (1)

COV795

EXPERIMENTAL

Participants receive 2 tablets of COV795 every 12 hours for up to 35 days

Drug: COV795

Interventions

COV795 DRUG

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

Also known as: MNK795

COV795

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be considered in general good health based upon medical and surgical history, vital signs, pulse oximetry, physical exam, clinical lab tests, and electrocardiogram (ECG).
• Be ≥18 years of age
• 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
• 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
• 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
• 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.
• Have a pain intensity score of ≥4 on NRS as an average for the last 24 hours at baseline visit.
• Must, in the investigator's opinion, qualify for opioid therapy for their CLBP or OA.
• Voluntarily provide written informed consent.

You may not qualify if:

• 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
• Have an uncontrolled or poorly controlled major psychiatric condition, or have clinically significant anxiety or depression
• Have an active malignancy or history of malignancy within 2 years
• Have a history of seizures (except pediatric febrile seizures) or cognitive dysfunction
• Have clinically significant ECG abnormalities or have uncontrolled hypo- or hypertension
• Had arthroscopic or open surgery on either knee or hip selected as the primary OA study joint within 6 months
• For CLBP, had a surgical procedure for back pain within 6 months
• 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.
• Had surgical implants of either the knee or hip selected as the primary OA joint
• Had gastric reduction surgery
• 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
• Unable to discontinue use of prohibited medications
• Have a known allergy or hypersensitivity to opioids, OC, acetaminophen (APAP) or ibuprofen.
• Have abnormal clinical laboratory tests at screening
• Have a history of substance or alcohol abuse

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (42)

Genova Clinical Research

Tucson, Arizona, 85704, United States

Location

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Orange County Research Institute

Anaheim, California, 92801, United States

Location

United Clinical Research Center, Inc.

Anaheim, California, 92804, United States

Location

Associated Pharmaceutical Research Center, Inc.

Buena Park, California, 90620, United States

Location

Catalina Research Institute, LLC

Chino, California, 91710, United States

Location

Synergy Escondido Clinical Research

Escondido, California, 92025, United States

Location

Convergys Clinical Research, Inc.

Fresno, California, 93726, United States

Location

Triwest Research Associates

La Mesa, California, 91942, United States

Location

Skyline Research, Inc.

Long Beach, California, 90806, United States

Location

Orthopedic Research Institute

Boynton Beach, Florida, 33472, United States

Location

Avail Clinical Research

DeLand, Florida, 32720, United States

Location

Eastern Research

Hialeah, Florida, 33013, United States

Location

Scientific Clinical Research, Inc.

North Miami, Florida, 33161, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32806, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Compass Research East, LLC

Oviedo, Florida, 32765, United States

Location

Gold Coast Research LLC

Plantation, Florida, 33317, United States

Location

Accord Clinical Research, LLC

Port Orange, Florida, 32129, United States

Location

Sarasota Pain Medicine Research, LLC

Sarasota, Florida, 34238, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Better Health Clinical Research

Newnan, Georgia, 30265, United States

Location

Chicago Anesthesia Pain Specialists

Chicago, Illinois, 60657, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

International Clinical Research Institute

Leawood, Kansas, 66211, United States

Location

Community Research

Crestview Hills, Kentucky, 41017, United States

Location

Commonwealth Biomedical Research, LLC

Madisonville, Kentucky, 42431, United States

Location

QUEST Research Institute

Bingham Farms, Michigan, 48025, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

Premier Research

Trenton, New Jersey, 08540, United States

Location

Peters Medical Research

High Point, North Carolina, 27262, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Hightop Medical Research Center/Hilltop Physicians Inc.

Cincinnati, Ohio, 45224, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Community Research

Cincinnati, Ohio, 45245, United States

Location

Allegheny Pain Management

Altoona, Pennsylvania, 16602, United States

Location

FutureSearch Trials

Austin, Texas, 78731, United States

Location

Austin Diagnostic Clinic

Austin, Texas, 78758, United States

Location

KRK Medical Research

Dallas, Texas, 75230, United States

Location

Optimum Clinical Research, Inc.

Salt Lake City, Utah, 84102, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Low Back Pain

Interventions

oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt

clinicaltrials@mnk.com

800-556-3314

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 13, 2011
• Study Start: September 20, 2011
• Primary Completion: June 18, 2012
• Study Completion: June 18, 2012
• Last Updated: September 18, 2020
• Results First Posted: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (42)