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

Osteoarthritis, Knee Clinical Trial

Official title:

An Open Label Safety Study of COV155 in Subjects With Osteoarthritis or Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722864
• Other study ID #: COV15010233
• Status: Completed
• Phase: Phase 3
• First received: November 5, 2012
• Last updated: October 18, 2016
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: October 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: August 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• 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

1. Not pregnant or lactating; not planning to become pregnant within next 60 days

2. 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

1. 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

2. 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

3. 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.

Exclusion Criteria

• 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

• Previously received COV155 in a study

• Received any investigational drugs or devices within 30 days prior to Screening

• Other criteria as specified in the protocol

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• COV155
COV155 tablets

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	Orange County Research Institute	Anaheim	California
United States	United Clinical Research Center, Inc.	Anaheim	California
United States	Clinical Study Center of Asheville, LLC	Asheville	North Carolina
United States	FutureSearch Trials of Neurology, LP	Austin	Texas
United States	Beacon Clinical Research, LLC	Brockton	Massachusetts
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	Community Research	Cincinnati	Ohio
United States	Community Research - Anderson	Cincinnati	Ohio
United States	Hightop Physicians Inc./Medical Research Center	Cincinnati	Ohio
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Lake Internal Medicine Associates	Eustis	Florida
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	DeGarmo Institute for Medical Research	Greer	South Carolina
United States	Eastern Research	Hialeah	Florida
United States	Palm Springs Research Institute	Hialeah	Florida
United States	Clinical Trial Network	Houston	Texas
United States	Goldpoint Clinical Research	Indianapolis	Indiana
United States	Health Awareness, Inc.	Jupiter	Florida
United States	Independent Clinical Researchers	Las Vegas	Nevada
United States	Torrance Clinical Research Inc.	Lomita	California
United States	Pain Specialists of Charleston	North Charleston	South Carolina
United States	Health Research Institute	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions Inc.	Orlando	Florida
United States	Compass Research, LLC	Orlando	Florida
United States	ClinRx Research LLC	Plano	Texas
United States	Martin E. Hale, MD PA (Gold Coast Research LLC)	Plantation	Florida
United States	Accord Clinical Research, LLC	Port Orange	Florida
United States	Wake Research Associates LLC	Raleigh	North Carolina
United States	Health Concepts	Rapid City	South Dakota
United States	Sun Research Institute	San Antonio	Texas
United States	International Clinical Research, LLC	Sanford	Florida
United States	Probe Clinical Research Corporation - Santa Ana	Santa Ana	California
United States	The Center for Clinical Research LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of COV155	Safety evaluations using physical exam, vital signs, clinical laboratory tests, pulse oximetry, and adverse events.	Up to 35 days	Yes
Secondary	Modified Brief Pain Inventory short form (mBPI-sf) - intensity	The mean changes from pre-treatment in the worst, least, average, and current pain using the worst, least, average, and current pain intensity items of the mBPI-sf (questions 1 to 4).	Baseline, Weeks 1, 2, 3, 4, and 5	No
Secondary	Modified Brief Pain Inventory short form (mBPI-sf) - pain relief	Evaluate pain relief using the pain relief item of the mBPI-sf (question 5).	Baseline, Weeks 1, 2, 3, 4, and 5	No
Secondary	Modified Brief Pain Inventory short form (mBPI-sf) - pain interference	Evaluate the pain-related quality of life using the Pain Interference subscale of the mBPI-sf.	Baseline, Weeks 1, 2, 3, 4, and 5	No
Secondary	Western Ontario and McMaster Universities Arthritis Index (WOMAC)	The mean changes from pre-treatment in disease-specific quality of life using the WOMAC (48-hour version) for subjects with OA of the hip or knee.	Baseline, Weeks 1, 2, 3, 4, and 5	No
Secondary	Roland Morris/Disability Questionnaire	The mean changes from pre-treatment in disease-specific quality of life using the Roland Morris LBP and Disability Questionnaire for subjects with CLBP.	Baseline, Weeks 1, 2, 3, 4, and 5	No