Open Label Safety and Tolerability Study of COV155 in Subjects With Osteoarthritis (OA) or Chronic Low Back Pain (CLBP)

NCT01722864 | Completed Phase 3

• 1 other identifier: COV15010233
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 34

Brief Summary

A study to show the safety of COV155 in patients with osteoarthritis of the knee or hip or moderate to severe chronic low back pain.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of COV155

  Safety evaluations using physical exam, vital signs, clinical laboratory tests, pulse oximetry, and adverse events.

  Up to 35 days

Secondary Outcomes (5)

• Modified Brief Pain Inventory short form (mBPI-sf) - intensity

  Baseline, Weeks 1, 2, 3, 4, and 5

• Modified Brief Pain Inventory short form (mBPI-sf) - pain relief

  Baseline, Weeks 1, 2, 3, 4, and 5

• Modified Brief Pain Inventory short form (mBPI-sf) - pain interference

  Baseline, Weeks 1, 2, 3, 4, and 5

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  Baseline, Weeks 1, 2, 3, 4, and 5

• Roland Morris/Disability Questionnaire

  Baseline, Weeks 1, 2, 3, 4, and 5

Study Arms (1)

COV155

EXPERIMENTAL

COV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 10 to 35 days.

Drug: COV155

Interventions

COV155 DRUG

COV155 tablets

Also known as: MNK155

COV155

Eligibility Criteria

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

You may qualify if:

• General good health, other than osteoarthritis (OA) or chronic low back pain (CLBP), based upon results of medical and surgical history and medical exam
• ≥18 years of age
• Voluntarily provide written informed consent
• Female subjects eligible if
• Not pregnant or lactating; not planning to become pregnant within next 60 days
• Surgically sterile, or 2 years postmenopausal, or practicing acceptable birth control for more than 60 days prior to Screening and use of acceptable birth control during the study and 7 days following the last dose of COV155
• Male subjects biologically capable of having children must use reliable birth control during study and 7 days after the last dose of COV155. Surgical sterilization of the subject's monogamous partner qualifies as adequate birth control
• Clinical diagnosis of one of the following
• OA of knee or hip for at least 1 year with moderate to severe daily pain despite chronic use of stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) or other non-steroidal, non-opioid therapies or with therapy including opioids
• Moderate to severe CLBP for at least several hours a day for a minimum of 90 days, not due to a known malignancy, and classified as non-neuropathic, neuropathic, or symptomatic for more than 6 months after LBP surgery
• OA of knee and scheduled to undergo unilateral primary tricompartmental arthroplasty.
• For CLBP/OA: Average in-clinic pain score of ≥3 on 11-point (0 to 10) numerical rating scale (NRS) as an average for the last 24 hours at Screening; - Pain intensity score of ≥4 on NRS as an average for the last 24 hours at Baseline
• For TKR: 11. Post-operative pain intensity scores ≥ 4 on a 0 to 10 NRS after discontinuation of post-surgical patient controlled analgesia or intravenous pain medications; body mass index ≤ 38.0; classified as either Physical Status (PS)-1 or PS-2.

You may not qualify if:

• Any clinically significant condition or unstable illness that precludes study participation or interferes with assessment of pain and other symptoms of CLBP or OA or would increase the risk of opioid or NSAID related adverse events
• Schizophrenia or an uncontrolled or poorly controlled major psychiatric condition or clinically significant anxiety or depression
• Active malignancy or history of malignancy within 2 years prior to Screening other than dermal or cervical squamous cell carcinoma in situ
• History of seizures (exception-pediatric febrile seizures)
• Clinically significant ECG abnormalities or uncontrolled hypo- or hypertension
• For CLBP/OA: Arthroscopic or open surgery on either the knee or hip selected as primary OA study joint within 6 months prior to Screening; - For CLBP subjects, a surgical procedure for back pain within 6 months prior to Screening, nerve or plexus block within 30 days prior to Screening or botulinum toxin injection in lower back region within 90 days prior to Screening. For OA subjects, joint injection within 30 days prior to Screening; - Surgical implants of either the knee or hip selected as the primary OA joint; history of spinal stenosis (only CLBP subjects)
• For TKR: Major prior open knee surgery on same side as arthroplasty; any other surgery/elective procedures within 4 weeks of Screening, or during study; going to rehabilitation after surgery
• Gastric reduction or gastric band surgery
• Taking opioids in equivalents to more than 20 mg hydrocodone or more than 40 mg morphine orally per day, or taking opioid medications 4 days a week or more
• Known allergy or hypersensitivity to opioids, acetaminophen or ibuprofen
• Certain lab abnormalities
• Unable to discontinue use of prohibited medications or history of substance or alcohol abuse within 2 years prior to Screening or positive urine drug test at Screening for alcohol, illicit drugs (including medical cannabis) or controlled substances other than prescribed medications
• Positive for human immunodeficiency virus, hepatitis B (surface antigen), and/or hepatitis C
• Any other chronic pain condition other than CLBP or OA that would interfere with the assessment of CLBP or OA
• Used a monoamine oxidase inhibitor, antipsychotic, or benzodiazepine within 14 days prior to Screening or started or changed doses of anticonvulsants, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, or tricyclic antidepressants within 30 days prior to Screening

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (34)

Anaheim Clinical Trials

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

Torrance Clinical Research Inc.

Lomita, California, 90717, United States

Location

Probe Clinical Research Corporation - Santa Ana

Santa Ana, California, 92701, United States

Location

Lake Internal Medicine Associates

Eustis, Florida, 32726, United States

Location

Palm Springs Research Institute

Hialeah, Florida, 33012, United States

Location

Eastern Research

Hialeah, Florida, 33013, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Clinical Neuroscience Solutions Inc.

Orlando, Florida, 32806, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Martin E. Hale, MD PA (Gold Coast Research LLC)

Plantation, Florida, 33317, United States

Location

Accord Clinical Research, LLC

Port Orange, Florida, 32129, United States

Location

International Clinical Research, LLC

Sanford, Florida, 32771, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Goldpoint Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Beacon Clinical Research, LLC

Brockton, Massachusetts, 02301, United States

Location

Independent Clinical Researchers

Las Vegas, Nevada, 89103, United States

Location

Clinical Study Center of Asheville, LLC

Asheville, North Carolina, 28803, United States

Location

Wake Research Associates LLC

Raleigh, North Carolina, 27612, United States

Location

The Center for Clinical Research LLC

Winston-Salem, North Carolina, 27103, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 42542, United States

Location

Hightop Physicians Inc./Medical Research Center

Cincinnati, Ohio, 45224, United States

Location

Community Research

Cincinnati, Ohio, 45227, United States

Location

Community Research - Anderson

Cincinnati, Ohio, 45255, United States

Location

Health Research Institute

Oklahoma City, Oklahoma, 73109, United States

Location

DeGarmo Institute for Medical Research

Greer, South Carolina, 29651, United States

Location

Pain Specialists of Charleston

North Charleston, South Carolina, 29406, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

FutureSearch Trials of Neurology, LP

Austin, Texas, 78731, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

ClinRx Research LLC

Plano, Texas, 75023, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, 22911, United States

Location

Related Publications (1)

• Zheng Y, Kostenbader K, Barrett T, Hisaw E, Giuliani MJ, Chen Y, Young JL. Tolerability of Biphasic-Release Hydrocodone Bitartrate/Acetaminophen Tablets (MNK-155): A Phase III, Multicenter, Open-Label Study in Patients With Osteoarthritis or Chronic Low Back Pain. Clin Ther. 2015 Jun 1;37(6):1235-47. doi: 10.1016/j.clinthera.2015.03.019. Epub 2015 Apr 23.

  PMID: 25913923 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

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: November 5, 2012
• First Posted: November 7, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

US (34)