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Osteoarthritis, KneePhase 3NCT01722864

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

A Phase 3 study testing COV155 in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Mallinckrodt at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
COV155
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
34 sitesUnited States
Study dates
Nov 2012to Aug 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • Anaheim Clinical Trials

    Anaheim, California, 92801

  • Orange County Research Institute

    Anaheim, California, 92801

  • United Clinical Research Center, Inc.

    Anaheim, California, 92804

  • Clinical Study Center of Asheville, LLC

    Asheville, North Carolina, 28803

  • FutureSearch Trials of Neurology, LP

    Austin, Texas, 78731

  • Beacon Clinical Research, LLC

    Brockton, Massachusetts, 02301

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911

  • New Horizons Clinical Research

    Cincinnati, Ohio, 42542

  • Hightop Physicians Inc./Medical Research Center

    Cincinnati, Ohio, 45224

  • Community Research

    Cincinnati, Ohio, 45227

  • Community Research - Anderson

    Cincinnati, Ohio, 45255

  • Lake Internal Medicine Associates

    Eustis, Florida, 32726

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • DeGarmo Institute for Medical Research

    Greer, South Carolina, 29651

  • Palm Springs Research Institute

    Hialeah, Florida, 33012

  • Eastern Research

    Hialeah, Florida, 33013

  • Clinical Trial Network

    Houston, Texas, 77074

  • Goldpoint Clinical Research

    Indianapolis, Indiana, 46260

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Independent Clinical Researchers

    Las Vegas, Nevada, 89103

  • Torrance Clinical Research Inc.

    Lomita, California, 90717

  • Pain Specialists of Charleston

    North Charleston, South Carolina, 29406

  • Health Research Institute

    Oklahoma City, Oklahoma, 73109

  • Clinical Neuroscience Solutions Inc.

    Orlando, Florida, 32806

  • Compass Research, LLC

    Orlando, Florida, 32806

  • ClinRx Research LLC

    Plano, Texas, 75023

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

    Plantation, Florida, 33317

  • Accord Clinical Research, LLC

    Port Orange, Florida, 32129

  • Wake Research Associates LLC

    Raleigh, North Carolina, 27612

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Sun Research Institute

    San Antonio, Texas, 78215

  • International Clinical Research, LLC

    Sanford, Florida, 32771

  • Probe Clinical Research Corporation - Santa Ana

    Santa Ana, California, 92701

  • The Center for Clinical Research LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Being tested
COV155
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COV155Drug

    Also called MNK155

    COV155 tablets

Study groups in NCT01722864
Study groupRoleWhat they receive
COV155ExperimentalCOV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 10 to 35 days.
Receives: Drug: COV155

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of COV155

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

    Measured: Up to 35 days

Secondary outcomes (5)

  1. 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).

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

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

    Evaluate pain relief using the pain relief item of the mBPI-sf (question 5).

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionFeb 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01722864
Sponsor's protocol ID
COV15010233
Status last verified
Oct 2016
First submitted
5 Nov 2012
Last updated
19 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25913923

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing COV155 in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Mallinckrodt at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of COV155 (time frame: Up to 35 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01722864, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.

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