<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/NCT03025113</url>
  </required_header>
  <id_info>
    <org_study_id>EMS0116</org_study_id>
    <nct_id>NCT03025113</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment</brief_title>
  <official_title>Phase III, National, Multicenter, Randomized, Double-blind, Double-Masked, Compare the Efficacy of Ketoprofen + Cyclobenzaprine Association Versus Cyclobenzaprine (Miosan®) in the Treatment of Osteomuscular Pain in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EMS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EMS</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of an association with one&#xD;
      anti-inflammatory and one muscle relaxant agent compared to the one muscle relaxant agent&#xD;
      isolated in the treatment of osteomuscular pain in adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Double-blind, randomized, multicenter&#xD;
&#xD;
        -  Maximal experiment duration: 9 days&#xD;
&#xD;
        -  02 or 03 visits and a phone contact&#xD;
&#xD;
        -  Evaluate the efficacy of an association with one anti-inflammatory and one muscle&#xD;
           relaxant agent compared to the one muscle relaxant agent isolated in the treatment of&#xD;
           osteomuscular pain in adults.&#xD;
&#xD;
        -  Adverse events evaluation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2018</start_date>
  <completion_date type="Actual">March 27, 2020</completion_date>
  <primary_completion_date type="Actual">November 29, 2019</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety will be evaluated by the adverse events occurrences</measure>
    <time_frame>Maximal experiment duration: 9 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">416</enrollment>
  <condition>Musculoskeletal Pain</condition>
  <arm_group>
    <arm_group_label>EMS association</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Miosan®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient will take 2 tablets (cyclobenzaprine isolated), oral, per day, each 12h.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ketoprofen and cyclobenzaprine association</intervention_name>
    <description>The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.</description>
    <arm_group_label>EMS association</arm_group_label>
    <other_name>EMS association</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclobenzaprine</intervention_name>
    <description>The patient will take 2 tablets (cyclobenzaprine), oral, per day, each 12h.</description>
    <arm_group_label>Miosan®</arm_group_label>
    <other_name>Miosan®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        IInclusion Criteria:&#xD;
&#xD;
          -  Signed Consent of the patient;&#xD;
&#xD;
          -  Participants presenting musculoskeletal pain, moderate or moderately severe, with VAS&#xD;
             (visual analog scale) greater than 40 mm for a period of less than seven (7) days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any clinically significant disease that in the investigator is opinion&#xD;
             can´t participate in the study;&#xD;
&#xD;
          -  Patients with any laboratory finding or image finding that in the investigator is&#xD;
             opinion can´t participate in the clinical trial;&#xD;
&#xD;
          -  Patients with history of hypersensitivity to any of the formula compounds;&#xD;
&#xD;
          -  Participation in clinical trial in the year prior to this study;&#xD;
&#xD;
          -  Pregnancy or risk of pregnancy and lactating patients;&#xD;
&#xD;
          -  Patients who were in use of drugs that can interfere with evaluation;&#xD;
&#xD;
          -  History of with rheumatic diseases, fibromyalgia, osteoarticular diseases, dystonia,&#xD;
             dystrophies and myopathies, acute infectious diseases, gastric duodenal ulcer or&#xD;
             gastritis;&#xD;
&#xD;
          -  Renal or hepatic impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Allegisa</name>
      <address>
        <city>Campinas</city>
        <state>São Paulo</state>
        <zip>13.084-791</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 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>Musculoskeletal Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketoprofen</mesh_term>
    <mesh_term>Amitriptyline</mesh_term>
    <mesh_term>Cyclobenzaprine</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/NCT03025113
org study id: EMS0116
nct id: NCT03025113
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety and efficacy of an association with one
      anti-inflammatory and one muscle relaxant agent compared to the one muscle relaxant agent
      isolated in the treatment of osteomuscular pain in adults.
-  Double-blind, randomized, multicenter

        -  Maximal experiment duration: 9 days

        -  02 or 03 visits and a phone contact

        -  Evaluate the efficacy of an association with one anti-inflammatory and one muscle
           relaxant agent compared to the one muscle relaxant agent isolated in the treatment of
           osteomuscular pain in adults.

        -  Adverse events evaluation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.
time frame: 48 hours
measure: Safety will be evaluated by the adverse events occurrences
time frame: Maximal experiment duration: 9 days
arm group label: EMS association
arm group type: Experimental
description: The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.
arm group label: Miosan®
arm group type: Active Comparator
description: The patient will take 2 tablets (cyclobenzaprine isolated), oral, per day, each 12h.
intervention type: Drug
intervention name: ketoprofen and cyclobenzaprine association
description: The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.
arm group label: EMS association
other name: EMS association
intervention type: Drug
intervention name: Cyclobenzaprine
description: The patient will take 2 tablets (cyclobenzaprine), oral, per day, each 12h.
arm group label: Miosan®
other name: Miosan®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Musculoskeletal Pain
mesh term: Ketoprofen
mesh term: Amitriptyline
mesh term: Cyclobenzaprine