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

October 18, 2016 updated by: Mallinckrodt

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials
      • Anaheim, California, United States, 92804
        • United Clinical Research Center, Inc.
      • Anaheim, California, United States, 92801
        • Orange County Research Institute
      • Lomita, California, United States, 90717
        • Torrance Clinical Research Inc.
      • Santa Ana, California, United States, 92701
        • Probe Clinical Research Corporation - Santa Ana
    • Florida
      • Eustis, Florida, United States, 32726
        • Lake Internal Medicine Associates
      • Hialeah, Florida, United States, 33012
        • Palm Springs Research Institute
      • Hialeah, Florida, United States, 33013
        • Eastern Research
      • Jupiter, Florida, United States, 33458
        • Health Awareness, Inc.
      • Orlando, Florida, United States, 32806
        • Compass Research, LLC
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions Inc.
      • Plantation, Florida, United States, 33317
        • Martin E. Hale, MD PA (Gold Coast Research LLC)
      • Port Orange, Florida, United States, 32129
        • Accord Clinical Research, LLC
      • Sanford, Florida, United States, 32771
        • International Clinical Research, LLC
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
      • Indianapolis, Indiana, United States, 46260
        • Goldpoint Clinical Research
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Beacon Clinical Research, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89103
        • Independent Clinical Researchers
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Clinical Study Center of Asheville, LLC
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates Llc
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Community Research
      • Cincinnati, Ohio, United States, 45255
        • Community Research - Anderson
      • Cincinnati, Ohio, United States, 42542
        • New Horizons Clinical Research
      • Cincinnati, Ohio, United States, 45224
        • Hightop Physicians Inc./Medical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Health Research Institute
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • DeGarmo Institute for Medical Research
      • North Charleston, South Carolina, United States, 29406
        • Pain Specialists of Charleston
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology, LP
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Plano, Texas, United States, 75023
        • ClinRx Research LLC
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research Center, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: COV155
COV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 10 to 35 days.
Drug: COV155
COV155 tablets
Other Names:
  • MNK155

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability of COV155
Time Frame: Up to 35 days
Safety evaluations using physical exam, vital signs, clinical laboratory tests, pulse oximetry, and adverse events.
Up to 35 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified Brief Pain Inventory short form (mBPI-sf) - intensity
Time Frame: Baseline, Weeks 1, 2, 3, 4, and 5
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
Modified Brief Pain Inventory short form (mBPI-sf) - pain relief
Time Frame: Baseline, Weeks 1, 2, 3, 4, and 5
Evaluate pain relief using the pain relief item of the mBPI-sf (question 5).
Baseline, Weeks 1, 2, 3, 4, and 5
Modified Brief Pain Inventory short form (mBPI-sf) - pain interference
Time Frame: Baseline, Weeks 1, 2, 3, 4, and 5
Evaluate the pain-related quality of life using the Pain Interference subscale of the mBPI-sf.
Baseline, Weeks 1, 2, 3, 4, and 5
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: Baseline, Weeks 1, 2, 3, 4, and 5
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
Roland Morris/Disability Questionnaire
Time Frame: Baseline, Weeks 1, 2, 3, 4, and 5
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mallinckrodt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COV15010233

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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