<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/NCT01708915</url>
  </required_header>
  <id_info>
    <org_study_id>69.52</org_study_id>
    <secondary_id>2011-003890-27</secondary_id>
    <nct_id>NCT01708915</nct_id>
  </id_info>
  <brief_title>Nonivamide/Nicoboxil Ointment in Acute Low Back Pain</brief_title>
  <official_title>A Multi-centre, Double-blind, Randomised, Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of Topically Applied Hyperemisation-inducing Ointment (2cm Ointment Line Per Application; up to 3 Times Daily for up to 4 Days) Containing 2.5% Nicoboxil/0.4% Nonivamide Versus 2.5% Nicoboxil, 0.4% Nonivamide and Placebo in Patients 18 to 65 Years of Age With Acute Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide&#xD;
      ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of&#xD;
      acute low back pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 3</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</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application</measure>
    <time_frame>Baseline and 8 hours after first ointment application</time_frame>
    <description>Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after first ointment application. Means were adjusted for centre effect and baseline value.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application</measure>
    <time_frame>Baseline and 4 hours after first ointment application</time_frame>
    <description>Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after first ointment application. Means were adjusted for centre effect and baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day</measure>
    <time_frame>Baseline and 1 to 4 days</time_frame>
    <description>Average pain intensity was assessed in the evening of days 1, 2, 3 and 4 on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible). The last individual treatment day is the last day with diary-recorded ointment application. Means were adjusted for centre effect and baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Assessment of Efficacy on the Last Individual Treatment Day</measure>
    <time_frame>1 to 4 days</time_frame>
    <description>Patient assessment of efficacy was assessed on a 4-point verbal rating scale (VRS, 0 = 'poor', 1 = 'fair', 2 = 'good', 3 = 'very good' relief of the patients' low back pain) in the evening of days 1, 2, 3 and 4. The last individual treatment day is the last day with diary-recorded ointment application</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">805</enrollment>
  <condition>Acute Low Back Pain</condition>
  <arm_group>
    <arm_group_label>nonivamide + nicoboxil (Finalgon)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nonivamide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nicoboxil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nicoboxil</intervention_name>
    <description>2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period</description>
    <arm_group_label>nicoboxil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo matching nonivamide + nicoboxil</intervention_name>
    <description>2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nonivamide + nicoboxil (Finalgon)</intervention_name>
    <description>2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period</description>
    <arm_group_label>nonivamide + nicoboxil (Finalgon)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nonivamide</intervention_name>
    <description>2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period</description>
    <arm_group_label>nonivamide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients must sign and date an Informed Consent consistent with International&#xD;
             Conference on Hermonisation (ICH)/Good Clinical Practice (GCP) guidelines and local&#xD;
             regulation prior to participation in the trial.&#xD;
&#xD;
          -  Patients must agree to cooperate with all trial evaluations and perform all required&#xD;
             tasks.&#xD;
&#xD;
          -  Acute low back pain for more than 2 days and less than 21 days (= 3 weeks)&#xD;
&#xD;
          -  Male or female patients aged 18 to 65 years&#xD;
&#xD;
          -  Low back pain rating &gt;5 on a 0-10 numerical rating scale (NRS).&#xD;
&#xD;
          -  Female patients of childbearing potential may participate only in case of availability&#xD;
             of a negative urine pregnancy test and a confirmed menstrual period prior to study&#xD;
             entry and using a highly effective method of birth control. Highly effective methods&#xD;
             of birth control are defined as those which result in a low failure rate (i.e. less&#xD;
             than 1 % per year) when used consistently and correctly such as implants, injectables,&#xD;
             combined oral contraceptives, appropriate intrauterine devices, sexual abstinence or&#xD;
             vasectomised partner. Barrier methods of contraception (e.g. condom, diaphragma or&#xD;
             occlusive cap) are accepted if used in combination with spermicides (e.g. foam, gel).&#xD;
             Female patients will be considered being of childbearing potential unless surgically&#xD;
             sterilised by bilateral tubal ligation/salpingectomy or hysterectomy or&#xD;
             post-menopausal for at least one year.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Multilocular pain or panalgesia&#xD;
&#xD;
          -  History of more than three low back pain episodes in the last six months&#xD;
&#xD;
          -  Abnormal findings in at least one of the following assessments: Achilles tendon&#xD;
             reflex, patella reflex, heel walking, toe walking, cutaneous sensitivity of the legs&#xD;
             (including gluteal region), paresis tests in supine position upon dorsiflexion,&#xD;
             plantarflexion, hip flexion, knee extension&#xD;
&#xD;
          -  Bladder and/or rectum dysfunction&#xD;
&#xD;
          -  Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing&#xD;
             spondylitis), traumatic, or infective origins&#xD;
&#xD;
          -  Any condition, disease or concomitant treatment that in the judgement of the&#xD;
             Investigator will affect the subject's ability to participate in the clinical trial or&#xD;
             which will influence the test methodology used&#xD;
&#xD;
          -  Negative experience in the past with heat treatment for muscle complaints (e. g. hot&#xD;
             water bottle, heat pads, hyperemisation-inducing topical creams, ointments or patches)&#xD;
&#xD;
          -  History of treatment of back pain with centrally acting analgesics (e. g. opioids) and&#xD;
             muscle relaxants&#xD;
&#xD;
          -  Surgery due to back pain or rehabilitation due to back pain in the last 12 months&#xD;
&#xD;
          -  Spinal injection back pain treatment within 6 months prior to enrollment&#xD;
&#xD;
          -  Intake of antidepressant/antipsychotic medication within 4 weeks prior to enrollment&#xD;
&#xD;
          -  Treatment of the recent low back pain period with oral analgesics for more than 4&#xD;
             consecutive days&#xD;
&#xD;
          -  Locally applied medication to the back within 48 hours prior to enrollment (topical&#xD;
             treatments, injections)&#xD;
&#xD;
          -  Administration of other analgesics within 24 h prior to enrollment (exception: acetyl&#xD;
             salicylic acid (ASS) up to 100 mg/daily for anti platelet-aggregation therapy)&#xD;
&#xD;
          -  Non-pharmacological low back pain treatment (physiotherapy, heat treatment (e.g. hot&#xD;
             water bottle, heat patch, or massages) within 12 h prior to enrollment&#xD;
&#xD;
          -  Participation in an investigational drug or device trial within 4 weeks prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Hypersensitivity to Nicoboxil, Nonivamide, or paracetamol&#xD;
&#xD;
          -  Known hypersensitivity to any other ingredient, especially to sorbic acid/sorbate, to&#xD;
             citronella oil containing e.g. the fragrance compounds geraniol, citronellol and&#xD;
             citronellal, or to relevant flowers containing these compounds such as geranium,&#xD;
             lavender, jasmine or rose. For patients with known hypersensitivity to perfumes or&#xD;
             known type IV hypersensitivity to fragrance-mix I, the application of the&#xD;
             investigational product should be performed only with particular caution.&#xD;
&#xD;
          -  Skin lesions (e. g., rash, dermatitis, bruising, laceration) in the back region&#xD;
&#xD;
          -  Drug dependence and/or alcohol abuse&#xD;
&#xD;
          -  Severe hepatocellular insufficiency&#xD;
&#xD;
          -  Patients who are pregnant or breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>69.52.49007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Bad Lippspringe</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49026 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49032 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49033 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49041 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Einbeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49024 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49031 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49036 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Everswinkel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49039 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Fürth</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49018 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Goch</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49025 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Großheirath-Rossach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49022 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Haag</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49019 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49015 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Kaarst</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49042 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Karlsruhe-Rüppurr</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49027 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49035 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49040 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49013 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Köthen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49014 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Künzing</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49034 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Ludwigshafen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49028 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Meßkirch</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49030 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Meßkirch</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49029 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49012 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Neunkirchen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49020 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Rodgau</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49037 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Siegen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49016 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Stockach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49010 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Straßkirchen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49021 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Villingen-Schwenningen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49023 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Wangen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>69.52.49011 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Weilburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/69/69.52_U13-2315-01.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <results_first_submitted>April 17, 2014</results_first_submitted>
  <results_first_submitted_qc>April 17, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 15, 2014</results_first_posted>
  <last_update_submitted>May 20, 2014</last_update_submitted>
  <last_update_submitted_qc>May 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2014</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>Nicotinic Acids</mesh_term>
    <mesh_term>Capsaicin</mesh_term>
    <mesh_term>Nonivamide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Patients treated with placebo ointment</description>
        </group>
        <group group_id="P2">
          <title>Nicoboxil</title>
          <description>Patients treated with ointments containing 2.5% nicoboxil alone</description>
        </group>
        <group group_id="P3">
          <title>Nonivamide</title>
          <description>Patients treated with ointments containing 0.4% nonivamide alone</description>
        </group>
        <group group_id="P4">
          <title>Nicoboxil/Nonivamide</title>
          <description>Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="204"/>
                <participants group_id="P2" count="201"/>
                <participants group_id="P3" count="198"/>
                <participants group_id="P4" count="202"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="118"/>
                <participants group_id="P2" count="139"/>
                <participants group_id="P3" count="152"/>
                <participants group_id="P4" count="169"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
                <participants group_id="P2" count="62"/>
                <participants group_id="P3" count="46"/>
                <participants group_id="P4" count="33"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="35"/>
                <participants group_id="P4" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reasons than stated above</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients from Treated Set (TS): Patients who were randomised and who used at least 1 dose of study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Patients treated with placebo ointment</description>
        </group>
        <group group_id="B2">
          <title>Nicoboxil</title>
          <description>Patients treated with ointments containing 2.5% nicoboxil alone</description>
        </group>
        <group group_id="B3">
          <title>Nonivamide</title>
          <description>Patients treated with ointments containing 0.4% nonivamide alone</description>
        </group>
        <group group_id="B4">
          <title>Nicoboxil/Nonivamide</title>
          <description>Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="204"/>
            <count group_id="B2" value="201"/>
            <count group_id="B3" value="198"/>
            <count group_id="B4" value="202"/>
            <count group_id="B5" value="805"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.2" spread="13.27"/>
                    <measurement group_id="B2" value="40.4" spread="13.06"/>
                    <measurement group_id="B3" value="42.2" spread="13.53"/>
                    <measurement group_id="B4" value="40.2" spread="14.31"/>
                    <measurement group_id="B5" value="40.5" spread="13.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="103"/>
                    <measurement group_id="B4" value="100"/>
                    <measurement group_id="B5" value="388"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="110"/>
                    <measurement group_id="B3" value="95"/>
                    <measurement group_id="B4" value="102"/>
                    <measurement group_id="B5" value="417"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application</title>
        <description>Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after first ointment application. Means were adjusted for centre effect and baseline value.</description>
        <time_frame>Baseline and 8 hours after first ointment application</time_frame>
        <population>Patients from the Full Analysis Set (FAS): all randomised patients who used at least 1 dose of study medication and provided any post-treatment data for the pain intensity difference within 8 hours after first application.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients treated with placebo ointment</description>
          </group>
          <group group_id="O2">
            <title>Nicoboxil</title>
            <description>Patients treated with ointments containing 2.5% nicoboxil alone</description>
          </group>
          <group group_id="O3">
            <title>Nonivamide</title>
            <description>Patients treated with ointments containing 0.4% nonivamide alone</description>
          </group>
          <group group_id="O4">
            <title>Nicoboxil/Nonivamide</title>
            <description>Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application</title>
          <description>Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after first ointment application. Means were adjusted for centre effect and baseline value.</description>
          <population>Patients from the Full Analysis Set (FAS): all randomised patients who used at least 1 dose of study medication and provided any post-treatment data for the pain intensity difference within 8 hours after first application.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="201"/>
                <count group_id="O3" value="198"/>
                <count group_id="O4" value="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.049" spread="0.106"/>
                    <measurement group_id="O2" value="-1.428" spread="0.109"/>
                    <measurement group_id="O3" value="-2.252" spread="0.141"/>
                    <measurement group_id="O4" value="-2.410" spread="0.138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.</p_value_desc>
            <method>Restricted Maximum Likelihood (REML)</method>
            <method_desc>REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.362</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.171</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.699</ci_lower_limit>
            <ci_upper_limit>-1.025</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.</p_value_desc>
            <method>Restricted Maximum Likelihood (REML)</method>
            <method_desc>REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.983</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.173</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.324</ci_lower_limit>
            <ci_upper_limit>-0.642</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4171</p_value>
            <p_value_desc>Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.</p_value_desc>
            <method>Restricted Maximum Likelihood (REML)</method>
            <method_desc>REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.158</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.195</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.541</ci_lower_limit>
            <ci_upper_limit>0.225</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application</title>
        <description>Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after first ointment application. Means were adjusted for centre effect and baseline value.</description>
        <time_frame>Baseline and 4 hours after first ointment application</time_frame>
        <population>Patients from FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients treated with placebo ointment</description>
          </group>
          <group group_id="O2">
            <title>Nicoboxil</title>
            <description>Patients treated with ointments containing 2.5% nicoboxil alone</description>
          </group>
          <group group_id="O3">
            <title>Nonivamide</title>
            <description>Patients treated with ointments containing 0.4% nonivamide alone</description>
          </group>
          <group group_id="O4">
            <title>Nicoboxil/Nonivamide</title>
            <description>Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application</title>
          <description>Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after first ointment application. Means were adjusted for centre effect and baseline value.</description>
          <population>Patients from FAS.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="201"/>
                <count group_id="O3" value="198"/>
                <count group_id="O4" value="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.650" spread="0.077"/>
                    <measurement group_id="O2" value="-0.968" spread="0.091"/>
                    <measurement group_id="O3" value="-1.641" spread="0.110"/>
                    <measurement group_id="O4" value="-1.699" spread="0.109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.</p_value_desc>
            <method>Restricted Maximum Likelihood (REML)</method>
            <method_desc>REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.049</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.130</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.305</ci_lower_limit>
            <ci_upper_limit>-0.793</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.</p_value_desc>
            <method>Restricted Maximum Likelihood (REML)</method>
            <method_desc>REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.731</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.138</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.003</ci_lower_limit>
            <ci_upper_limit>-0.459</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7037</p_value>
            <p_value_desc>Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.</p_value_desc>
            <method>Restricted Maximum Likelihood (REML)</method>
            <method_desc>REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.058</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.152</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.356</ci_lower_limit>
            <ci_upper_limit>0.241</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day</title>
        <description>Average pain intensity was assessed in the evening of days 1, 2, 3 and 4 on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible). The last individual treatment day is the last day with diary-recorded ointment application. Means were adjusted for centre effect and baseline value.</description>
        <time_frame>Baseline and 1 to 4 days</time_frame>
        <population>Patients from FAS with evaluable data for the pain intensity at baseline and for the avarage pain intensity on the last individual treatment day.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients treated with placebo ointment</description>
          </group>
          <group group_id="O2">
            <title>Nicoboxil</title>
            <description>Patients treated with ointments containing 2.5% nicoboxil alone</description>
          </group>
          <group group_id="O3">
            <title>Nonivamide</title>
            <description>Patients treated with ointments containing 0.4% nonivamide alone</description>
          </group>
          <group group_id="O4">
            <title>Nicoboxil/Nonivamide</title>
            <description>Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide</description>
          </group>
        </group_list>
        <measure>
          <title>Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day</title>
          <description>Average pain intensity was assessed in the evening of days 1, 2, 3 and 4 on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible). The last individual treatment day is the last day with diary-recorded ointment application. Means were adjusted for centre effect and baseline value.</description>
          <population>Patients from FAS with evaluable data for the pain intensity at baseline and for the avarage pain intensity on the last individual treatment day.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
                <count group_id="O2" value="200"/>
                <count group_id="O3" value="198"/>
                <count group_id="O4" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.884" spread="0.160"/>
                    <measurement group_id="O2" value="-2.371" spread="0.160"/>
                    <measurement group_id="O3" value="-3.074" spread="0.161"/>
                    <measurement group_id="O4" value="-3.540" spread="0.159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>The statistical model included baseline PI, centre, and treatment.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.655</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.208</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-2.064</ci_lower_limit>
            <ci_upper_limit>-1.247</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>The statistical model included baseline PI, centre, and treatment.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.169</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.209</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.578</ci_lower_limit>
            <ci_upper_limit>-0.759</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0259</p_value>
            <method>ANCOVA</method>
            <method_desc>The statistical model included baseline PI, centre, and treatment.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.466</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.209</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.875</ci_lower_limit>
            <ci_upper_limit>-0.056</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Assessment of Efficacy on the Last Individual Treatment Day</title>
        <description>Patient assessment of efficacy was assessed on a 4-point verbal rating scale (VRS, 0 = 'poor', 1 = 'fair', 2 = 'good', 3 = 'very good' relief of the patients' low back pain) in the evening of days 1, 2, 3 and 4. The last individual treatment day is the last day with diary-recorded ointment application</description>
        <time_frame>1 to 4 days</time_frame>
        <population>Patients from FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patients treated with placebo ointment</description>
          </group>
          <group group_id="O2">
            <title>Nicoboxil</title>
            <description>Patients treated with ointments containing 2.5% nicoboxil alone</description>
          </group>
          <group group_id="O3">
            <title>Nonivamide</title>
            <description>Patients treated with ointments containing 0.4% nonivamide alone</description>
          </group>
          <group group_id="O4">
            <title>Nicoboxil/Nonivamide</title>
            <description>Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Assessment of Efficacy on the Last Individual Treatment Day</title>
          <description>Patient assessment of efficacy was assessed on a 4-point verbal rating scale (VRS, 0 = 'poor', 1 = 'fair', 2 = 'good', 3 = 'very good' relief of the patients' low back pain) in the evening of days 1, 2, 3 and 4. The last individual treatment day is the last day with diary-recorded ointment application</description>
          <population>Patients from FAS.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="201"/>
                <count group_id="O3" value="198"/>
                <count group_id="O4" value="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" spread="0.160"/>
                    <measurement group_id="O2" value="19" spread="0.160"/>
                    <measurement group_id="O3" value="34" spread="0.161"/>
                    <measurement group_id="O4" value="50" spread="0.159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="67"/>
                    <measurement group_id="O3" value="85"/>
                    <measurement group_id="O4" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="27"/>
                    <measurement group_id="O4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125"/>
                    <measurement group_id="O2" value="94"/>
                    <measurement group_id="O3" value="52"/>
                    <measurement group_id="O4" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Regression, Logistic</method>
            <method_desc>The logistic regression model included baseline PI, centre, and treatment.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>7.385</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>4.943</ci_lower_limit>
            <ci_upper_limit>11.032</ci_upper_limit>
            <estimate_desc>Odds Ratio was calculated by Nicoboxil/Nonivamide : Placebo. Odds ratios &gt; 1 favour Nicoboxil/Nonivamide.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Regression, Logistic</method>
            <method_desc>The logistic regression model included baseline PI, centre, and treatment.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.620</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>2.469</ci_lower_limit>
            <ci_upper_limit>5.308</ci_upper_limit>
            <estimate_desc>Odds Ratio was calculated by Nicoboxil/Nonivamide : Nicoboxil. Odds ratios &gt; 1 favour Nicoboxil/Nonivamide.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0129</p_value>
            <method>Regression, Logistic</method>
            <method_desc>The logistic regression model included baseline PI, centre, and treatment.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.594</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.104</ci_lower_limit>
            <ci_upper_limit>2.303</ci_upper_limit>
            <estimate_desc>Odds Ratio was calculated by Nicoboxil/Nonivamide : Nonivamide. Odds ratios &gt; 1 favour Nicoboxil/Nonivamide.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 4 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Patients treated with placebo ointment</description>
        </group>
        <group group_id="E2">
          <title>Nicoboxil</title>
          <description>Patients treated with ointments containing 2.5% nicoboxil alone</description>
        </group>
        <group group_id="E3">
          <title>Nonivamide</title>
          <description>Patients treated with ointments containing 0.4% nonivamide alone</description>
        </group>
        <group group_id="E4">
          <title>Nicoboxil/Nonivamide</title>
          <description>Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide alone</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MEDDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="201"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="202"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="201"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="198"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="202"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="201"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="202"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim Call Center</name_or_title>
      <organization>Boehringer Ingelheim Pharmaceuticals</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01708915
org study id: 69.52
secondary id: 2011-003890-27
nct id: NCT01708915
lead sponsor: 
The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide
      ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of
      acute low back pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application
time frame: Baseline and 8 hours after first ointment application
description: Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after first ointment application. Means were adjusted for centre effect and baseline value.
measure: Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application
time frame: Baseline and 4 hours after first ointment application
description: Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after first ointment application. Means were adjusted for centre effect and baseline value.
measure: Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day
time frame: Baseline and 1 to 4 days
description: Average pain intensity was assessed in the evening of days 1, 2, 3 and 4 on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible). The last individual treatment day is the last day with diary-recorded ointment application. Means were adjusted for centre effect and baseline value.
measure: Patient Assessment of Efficacy on the Last Individual Treatment Day
time frame: 1 to 4 days
description: Patient assessment of efficacy was assessed on a 4-point verbal rating scale (VRS, 0 = 'poor', 1 = 'fair', 2 = 'good', 3 = 'very good' relief of the patients' low back pain) in the evening of days 1, 2, 3 and 4. The last individual treatment day is the last day with diary-recorded ointment application
arm group label: nonivamide + nicoboxil (Finalgon)
arm group type: Active Comparator
description: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
arm group label: nonivamide
arm group type: Active Comparator
description: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
arm group label: nicoboxil
arm group type: Active Comparator
description: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
arm group label: placebo
arm group type: Placebo Comparator
description: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
intervention type: Drug
intervention name: nicoboxil
description: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
arm group label: nicoboxil
intervention type: Drug
intervention name: placebo matching nonivamide + nicoboxil
description: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
arm group label: placebo
intervention type: Drug
intervention name: nonivamide + nicoboxil (Finalgon)
description: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
arm group label: nonivamide + nicoboxil (Finalgon)
intervention type: Drug
intervention name: nonivamide
description: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
arm group label: nonivamide
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
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country: Germany
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/69/69.52_U13-2315-01.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Nicotinic Acids
mesh term: Capsaicin
mesh term: Nonivamide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 