<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01722864</url>
  </required_header>
  <id_info>
    <org_study_id>COV15010233</org_study_id>
    <nct_id>NCT01722864</nct_id>
  </id_info>
  <brief_title>Open Label Safety and Tolerability Study of COV155 in Subjects With Osteoarthritis (OA) or Chronic Low Back Pain (CLBP)</brief_title>
  <official_title>An Open Label Safety Study of COV155 in Subjects With Osteoarthritis or Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mallinckrodt</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mallinckrodt</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to show the safety of COV155 in patients with osteoarthritis of the knee or hip or&#xD;
      moderate to severe chronic low back pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability of COV155</measure>
    <time_frame>Up to 35 days</time_frame>
    <description>Safety evaluations using physical exam, vital signs, clinical laboratory tests, pulse oximetry, and adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Brief Pain Inventory short form (mBPI-sf) - intensity</measure>
    <time_frame>Baseline, Weeks 1, 2, 3, 4, and 5</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Brief Pain Inventory short form (mBPI-sf) - pain relief</measure>
    <time_frame>Baseline, Weeks 1, 2, 3, 4, and 5</time_frame>
    <description>Evaluate pain relief using the pain relief item of the mBPI-sf (question 5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Brief Pain Inventory short form (mBPI-sf) - pain interference</measure>
    <time_frame>Baseline, Weeks 1, 2, 3, 4, and 5</time_frame>
    <description>Evaluate the pain-related quality of life using the Pain Interference subscale of the mBPI-sf.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario and McMaster Universities Arthritis Index (WOMAC)</measure>
    <time_frame>Baseline, Weeks 1, 2, 3, 4, and 5</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Roland Morris/Disability Questionnaire</measure>
    <time_frame>Baseline, Weeks 1, 2, 3, 4, and 5</time_frame>
    <description>The mean changes from pre-treatment in disease-specific quality of life using the Roland Morris LBP and Disability Questionnaire for subjects with CLBP.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">153</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Osteoarthritis, Hip</condition>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>COV155</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 10 to 35 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>COV155</intervention_name>
    <description>COV155 tablets</description>
    <arm_group_label>COV155</arm_group_label>
    <other_name>MNK155</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  General good health, other than osteoarthritis (OA) or chronic low back pain (CLBP),&#xD;
             based upon results of medical and surgical history and medical exam&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  Voluntarily provide written informed consent&#xD;
&#xD;
          -  Female subjects eligible if&#xD;
&#xD;
               1. Not pregnant or lactating; not planning to become pregnant within next 60 days&#xD;
&#xD;
               2. Surgically sterile, or 2 years postmenopausal, or practicing acceptable birth&#xD;
                  control for more than 60 days prior to Screening and use of acceptable birth&#xD;
                  control during the study and 7 days following the last dose of COV155&#xD;
&#xD;
          -  Male subjects biologically capable of having children must use reliable birth control&#xD;
             during study and 7 days after the last dose of COV155. Surgical sterilization of the&#xD;
             subject's monogamous partner qualifies as adequate birth control&#xD;
&#xD;
          -  Clinical diagnosis of one of the following&#xD;
&#xD;
               1. OA of knee or hip for at least 1 year with moderate to severe daily pain despite&#xD;
                  chronic use of stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) or&#xD;
                  other non-steroidal, non-opioid therapies or with therapy including opioids&#xD;
&#xD;
               2. Moderate to severe CLBP for at least several hours a day for a minimum of 90&#xD;
                  days, not due to a known malignancy, and classified as non-neuropathic,&#xD;
                  neuropathic, or symptomatic for more than 6 months after LBP surgery&#xD;
&#xD;
               3. OA of knee and scheduled to undergo unilateral primary tricompartmental&#xD;
                  arthroplasty.&#xD;
&#xD;
          -  For CLBP/OA: Average in-clinic pain score of ≥3 on 11-point (0 to 10) numerical rating&#xD;
             scale (NRS) as an average for the last 24 hours at Screening; - Pain intensity score&#xD;
             of ≥4 on NRS as an average for the last 24 hours at Baseline&#xD;
&#xD;
          -  For TKR: 11. Post-operative pain intensity scores ≥ 4 on a 0 to 10 NRS after&#xD;
             discontinuation of post-surgical patient controlled analgesia or intravenous pain&#xD;
             medications; body mass index ≤ 38.0; classified as either Physical Status (PS)-1 or&#xD;
             PS-2.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Any clinically significant condition or unstable illness that precludes study&#xD;
             participation or interferes with assessment of pain and other symptoms of CLBP or OA&#xD;
             or would increase the risk of opioid or NSAID related adverse events&#xD;
&#xD;
          -  Schizophrenia or an uncontrolled or poorly controlled major psychiatric condition or&#xD;
             clinically significant anxiety or depression&#xD;
&#xD;
          -  Active malignancy or history of malignancy within 2 years prior to Screening other&#xD;
             than dermal or cervical squamous cell carcinoma in situ&#xD;
&#xD;
          -  History of seizures (exception-pediatric febrile seizures)&#xD;
&#xD;
          -  Clinically significant ECG abnormalities or uncontrolled hypo- or hypertension&#xD;
&#xD;
          -  For CLBP/OA: Arthroscopic or open surgery on either the knee or hip selected as&#xD;
             primary OA study joint within 6 months prior to Screening; - For CLBP subjects, a&#xD;
             surgical procedure for back pain within 6 months prior to Screening, nerve or plexus&#xD;
             block within 30 days prior to Screening or botulinum toxin injection in lower back&#xD;
             region within 90 days prior to Screening. For OA subjects, joint injection within 30&#xD;
             days prior to Screening; - Surgical implants of either the knee or hip selected as the&#xD;
             primary OA joint; history of spinal stenosis (only CLBP subjects)&#xD;
&#xD;
          -  For TKR: Major prior open knee surgery on same side as arthroplasty; any other&#xD;
             surgery/elective procedures within 4 weeks of Screening, or during study; going to&#xD;
             rehabilitation after surgery&#xD;
&#xD;
          -  Gastric reduction or gastric band surgery&#xD;
&#xD;
          -  Taking opioids in equivalents to more than 20 mg hydrocodone or more than 40 mg&#xD;
             morphine orally per day, or taking opioid medications 4 days a week or more&#xD;
&#xD;
          -  Known allergy or hypersensitivity to opioids, acetaminophen or ibuprofen&#xD;
&#xD;
          -  Certain lab abnormalities&#xD;
&#xD;
          -  Unable to discontinue use of prohibited medications or history of substance or alcohol&#xD;
             abuse within 2 years prior to Screening or positive urine drug test at Screening for&#xD;
             alcohol, illicit drugs (including medical cannabis) or controlled substances other&#xD;
             than prescribed medications&#xD;
&#xD;
          -  Positive for human immunodeficiency virus, hepatitis B (surface antigen), and/or&#xD;
             hepatitis C&#xD;
&#xD;
          -  Any other chronic pain condition other than CLBP or OA that would interfere with the&#xD;
             assessment of CLBP or OA&#xD;
&#xD;
          -  Used a monoamine oxidase inhibitor, antipsychotic, or benzodiazepine within 14 days&#xD;
             prior to Screening or started or changed doses of anticonvulsants, selective serotonin&#xD;
             reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, or tricyclic&#xD;
             antidepressants within 30 days prior to Screening&#xD;
&#xD;
          -  Previously received COV155 in a study&#xD;
&#xD;
          -  Received any investigational drugs or devices within 30 days prior to Screening&#xD;
&#xD;
          -  Other criteria as specified in the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Anaheim Clinical Trials</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange County Research Institute</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Clinical Research Center, Inc.</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Clinical Research Inc.</name>
      <address>
        <city>Lomita</city>
        <state>California</state>
        <zip>90717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Probe Clinical Research Corporation - Santa Ana</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Internal Medicine Associates</name>
      <address>
        <city>Eustis</city>
        <state>Florida</state>
        <zip>32726</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Springs Research Institute</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Research</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Awareness, Inc.</name>
      <address>
        <city>Jupiter</city>
        <state>Florida</state>
        <zip>33458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions Inc.</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Martin E. Hale, MD PA (Gold Coast Research LLC)</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33317</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accord Clinical Research, LLC</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Clinical Research, LLC</name>
      <address>
        <city>Sanford</city>
        <state>Florida</state>
        <zip>32771</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediSphere Medical Research Center, LLC</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Goldpoint Clinical Research</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beacon Clinical Research, LLC</name>
      <address>
        <city>Brockton</city>
        <state>Massachusetts</state>
        <zip>02301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Independent Clinical Researchers</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Study Center of Asheville, LLC</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Clinical Research LLC</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Horizons Clinical Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>42542</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hightop Physicians Inc./Medical Research Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Research - Anderson</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Research Institute</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DeGarmo Institute for Medical Research</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pain Specialists of Charleston</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Concepts</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FutureSearch Trials of Neurology, LP</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Network</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinRx Research LLC</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Research Institute</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlottesville Medical Research Center, LLC</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <disposition_first_submitted>October 10, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>October 10, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 20, 2014</disposition_first_posted>
  <last_update_submitted>October 18, 2016</last_update_submitted>
  <last_update_submitted_qc>October 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01722864
org study id: COV15010233
nct id: NCT01722864
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability of COV155
time frame: Up to 35 days
description: Safety evaluations using physical exam, vital signs, clinical laboratory tests, pulse oximetry, and adverse events.
measure: Modified Brief Pain Inventory short form (mBPI-sf) - intensity
time frame: Baseline, Weeks 1, 2, 3, 4, and 5
description: 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).
measure: Modified Brief Pain Inventory short form (mBPI-sf) - pain relief
time frame: Baseline, Weeks 1, 2, 3, 4, and 5
description: Evaluate pain relief using the pain relief item of the mBPI-sf (question 5).
measure: Modified Brief Pain Inventory short form (mBPI-sf) - pain interference
time frame: Baseline, Weeks 1, 2, 3, 4, and 5
description: Evaluate the pain-related quality of life using the Pain Interference subscale of the mBPI-sf.
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
time frame: Baseline, Weeks 1, 2, 3, 4, and 5
description: 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.
measure: Roland Morris/Disability Questionnaire
time frame: Baseline, Weeks 1, 2, 3, 4, and 5
description: The mean changes from pre-treatment in disease-specific quality of life using the Roland Morris LBP and Disability Questionnaire for subjects with CLBP.
arm group label: COV155
arm group type: Experimental
description: COV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 10 to 35 days.
intervention type: Drug
intervention name: COV155
description: COV155 tablets
arm group label: COV155
other name: MNK155
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Osteoarthritis, Hip
mesh term: Back Pain
mesh term: Low Back Pain