<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/NCT01725087</url>
  </required_header>
  <id_info>
    <org_study_id>KF6005/06</org_study_id>
    <secondary_id>2012-001920-36</secondary_id>
    <nct_id>NCT01725087</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.</brief_title>
  <official_title>Efficacy, Safety, and Tolerability of GRT6005 in Subjects With Moderate to Severe Chronic Low Back Pain.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tris Pharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Forest Laboratories</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tris Pharma, Inc.</source>
  <brief_summary>
    <textblock>
      The purpose of this trial is to evaluate the safety and efficacy of once daily orally&#xD;
      administered GRT6005 in a total of 3 fixed doses compared to placebo in subjects with&#xD;
      moderate to severe chronic Low Back Pain (LBP). The study includes a maximum of 21 days&#xD;
      screening period followed by a 2-week titration period and 12-week maintenance double-blind&#xD;
      treatment period and a 10-14 day safety follow up period. Patients who are eligible for the&#xD;
      double-blind treatment period will be randomized to one of the following treatment groups:&#xD;
      GRT6005 low-dose, GRT6005 medium dose, GRT6005 high-dose, Tapentadol or placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>European Union: the change from baseline pain to the weekly average 24-hour pain during the entire 12 weeks of the maintenance phase of the double-blind Treatment Period.</measure>
    <time_frame>Baseline to End of Treatment (Week 14)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>United States: the change from baseline pain to the average 24-hour pain during Week 12 of the maintenance phase.</measure>
    <time_frame>Baseline to End of Treatment (Week 14)</time_frame>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">1089</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Matching Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Twice daily oral administration of matching placebo for 14 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Dose GRT6005</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once daily GRT6005 low dose oral administration for 12 weeks with a titration period of 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium Dose GRT6005</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once daily GRT6005 medium dose oral administration for 12 weeks with a titration period of 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose GRT6005</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once daily GRT6005 high dose oral administration for 12 weeks with a titration period of 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tapentadol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Twice daily oral administration of Tapentadol for 12 weeks with a titration period of 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching Placebo</intervention_name>
    <arm_group_label>Matching Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low Dose GRT6005</intervention_name>
    <arm_group_label>Low Dose GRT6005</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medium Dose GRT6005</intervention_name>
    <arm_group_label>Medium Dose GRT6005</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High Dose GRT6005</intervention_name>
    <arm_group_label>High Dose GRT6005</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tapentadol</intervention_name>
    <arm_group_label>Tapentadol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic Low Back Pain of non-malignant origin and present for at least 3 months.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
          -  Pain intensity score of 5 or greater on the 11-point numeric rating scale (where 0&#xD;
             indicates &quot;no pain&quot; and 10 indicates &quot;as bad as you can imagine&quot;).&#xD;
&#xD;
          -  On stable analgesic medications (non-opioid and/or opioid medications) for chronic low&#xD;
             back pain with regular intake for at least 3 months and dissatisfied with current&#xD;
             analgesic treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female subjects who are pregnant or are breastfeeding.&#xD;
&#xD;
          -  Presence of risk factors for Torsade de Pointes.&#xD;
&#xD;
          -  Any clinically significant disease or laboratory findings that may affect efficacy or&#xD;
             safety assessments or may compromise the safety during trial participation, e.g.,&#xD;
             significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine,&#xD;
             metabolic, neurological, or psychiatric disorders.&#xD;
&#xD;
          -  History of acute hepatitis within the past 3 months or chronic hepatitis or a positive&#xD;
             result on anti-hepatitis A antibody, hepatitis B surface antigen, or anti-hepatitis C&#xD;
             antibody. History of human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          -  History of seizure disorder.&#xD;
&#xD;
          -  Chronic low back pain potentially associated with a specific spinal cause.&#xD;
&#xD;
          -  Surgery or painful procedure during or within 3 months of enrollment.&#xD;
&#xD;
          -  Conditions that contribute and confound the assessment of pain.&#xD;
&#xD;
          -  Subjects with impaired renal function.&#xD;
&#xD;
          -  Subjects with impaired hepatic functionality.&#xD;
&#xD;
          -  Neuromodulation.&#xD;
&#xD;
          -  Cancer.&#xD;
&#xD;
          -  Clinically relevant history of hypersensitivity, allergy or contraindications to any&#xD;
             of the Investigational Medicinal Products' excipients, paracetamol/acetaminophen,&#xD;
             tapentadol Hydrochloride, or opioid analgesics (or excipients).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Chair</role>
    <affiliation>Grünenthal GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AT003</name>
      <address>
        <city>Senftenberg</city>
        <zip>3541</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AT004</name>
      <address>
        <city>Wien</city>
        <zip>1060</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AT001</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>AT005</name>
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        <city>Wien</city>
        <zip>1100</zip>
        <country>Austria</country>
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      <name>AT006</name>
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        <city>Wien</city>
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        <country>Austria</country>
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  </location>
  <location>
    <facility>
      <name>BE001</name>
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        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
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  </location>
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      <name>BE002</name>
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        <city>Edegem</city>
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        <country>Belgium</country>
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      <name>BE004</name>
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        <city>Genk</city>
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      <name>DK004</name>
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    <facility>
      <name>Site DK002</name>
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    <facility>
      <name>DK003</name>
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      <name>ES008</name>
      <address>
        <city>Málaga</city>
        <zip>29009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES003</name>
      <address>
        <city>Oviedo</city>
        <zip>33009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES011</name>
      <address>
        <city>Oviedo</city>
        <zip>33013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES005</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15705</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES007</name>
      <address>
        <city>Sevilla</city>
        <zip>41071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SE001</name>
      <address>
        <city>Skene</city>
        <zip>51162</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SE002</name>
      <address>
        <city>Stockholm</city>
        <zip>11522</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SE004</name>
      <address>
        <city>Vällingby</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB002</name>
      <address>
        <city>Liverpool</city>
        <zip>L22 0LG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB005</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB003</name>
      <address>
        <city>Manchester</city>
        <zip>M15 6SX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB004</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>July 13, 2021</last_update_submitted>
  <last_update_submitted_qc>July 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2021</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>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tapentadol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01725087
org study id: KF6005/06
secondary id: 2012-001920-36
nct id: NCT01725087
lead sponsor: 
collaborator: 
The purpose of this trial is to evaluate the safety and efficacy of once daily orally
      administered GRT6005 in a total of 3 fixed doses compared to placebo in subjects with
      moderate to severe chronic Low Back Pain (LBP). The study includes a maximum of 21 days
      screening period followed by a 2-week titration period and 12-week maintenance double-blind
      treatment period and a 10-14 day safety follow up period. Patients who are eligible for the
      double-blind treatment period will be randomized to one of the following treatment groups:
      GRT6005 low-dose, GRT6005 medium dose, GRT6005 high-dose, Tapentadol or placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: European Union: the change from baseline pain to the weekly average 24-hour pain during the entire 12 weeks of the maintenance phase of the double-blind Treatment Period.
time frame: Baseline to End of Treatment (Week 14)
measure: United States: the change from baseline pain to the average 24-hour pain during Week 12 of the maintenance phase.
time frame: Baseline to End of Treatment (Week 14)
arm group label: Matching Placebo
arm group type: Placebo Comparator
description: Twice daily oral administration of matching placebo for 14 weeks
arm group label: Low Dose GRT6005
arm group type: Experimental
description: Once daily GRT6005 low dose oral administration for 12 weeks with a titration period of 2 weeks.
arm group label: Medium Dose GRT6005
arm group type: Experimental
description: Once daily GRT6005 medium dose oral administration for 12 weeks with a titration period of 2 weeks.
arm group label: High Dose GRT6005
arm group type: Experimental
description: Once daily GRT6005 high dose oral administration for 12 weeks with a titration period of 2 weeks.
arm group label: Tapentadol
arm group type: Active Comparator
description: Twice daily oral administration of Tapentadol for 12 weeks with a titration period of 2 weeks.
intervention type: Drug
intervention name: Matching Placebo
arm group label: Matching Placebo
intervention type: Drug
intervention name: Low Dose GRT6005
arm group label: Low Dose GRT6005
intervention type: Drug
intervention name: Medium Dose GRT6005
arm group label: Medium Dose GRT6005
intervention type: Drug
intervention name: High Dose GRT6005
arm group label: High Dose GRT6005
intervention type: Drug
intervention name: Tapentadol
arm group label: Tapentadol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Study Director
role: Study Chair
affiliation: Grünenthal GmbH
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country: Austria
country: Belgium
country: Denmark
country: Finland
country: Germany
country: Hungary
country: Netherlands
country: Poland
country: Spain
country: Sweden
country: United Kingdom
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Tapentadol