<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/NCT01670552</url>
  </required_header>
  <id_info>
    <org_study_id>NIPEMS1111</org_study_id>
    <nct_id>NCT01670552</nct_id>
  </id_info>
  <brief_title>Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients</brief_title>
  <official_title>Parallel Study, Double-blind, Randomized, to Compare the Safety of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety of an association with one&#xD;
      anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and&#xD;
      one gastroprotective agent in patients with acute or chronic osteoarticular inflammation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Double-blind,randomized, multicenter&#xD;
&#xD;
        -  Experiment duration: 14 days&#xD;
&#xD;
        -  03 visits&#xD;
&#xD;
        -  Evaluate the safety of an association with one anti-inflammatory and one&#xD;
           gastroprotective compared to association with one anti-inflammatory and one&#xD;
           gastroprotective agent in patients with acute or chronic osteoarticular inflammation&#xD;
&#xD;
        -  Adverse events evaluation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 17, 2016</start_date>
  <completion_date type="Actual">March 17, 2017</completion_date>
  <primary_completion_date type="Actual">October 28, 2016</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>Comparison relieve pain in patients with osteoarticular diseases and dyspeptic symptoms, defined as visual analogue scale (VAS) version modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events and dyspeptic complaints during the study</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">490</enrollment>
  <condition>Acute and Chronic Inflammation</condition>
  <condition>Dyspepsia</condition>
  <arm_group>
    <arm_group_label>Nimesulide + Pantoprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nimesulide + Pantoprazole- 1 tablet each 12 hours for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Naproxen + Esomeprazole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Naproxen + Esomeprazole - 1 tablet each 12 hours for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nimesulide + Pantoprazole</intervention_name>
    <description>1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Naproxen + Esomeprazole placebo.</description>
    <arm_group_label>Nimesulide + Pantoprazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naproxen + Esomeprazole</intervention_name>
    <description>1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Nimesulide + Pantoprazole placebo.</description>
    <arm_group_label>Naproxen + Esomeprazole</arm_group_label>
    <other_name>VIMOVO</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults male or female aged ≥ 18 years old;&#xD;
&#xD;
          -  Comply with all the purposes and procedures of the study by signing and dating the&#xD;
             Informed Consent.&#xD;
&#xD;
          -  Acute or chronic osteo-articular injury in need of of anti-inflammatory for a period&#xD;
             of 14 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women, or women in childbearing age who are not in use effective&#xD;
             contraception or intending to become pregnant during the study period&#xD;
&#xD;
          -  History of peptic ulcer or gastric surgery;&#xD;
&#xD;
          -  Use of Non-steroidal anti-inflammatory (NSAIDs), aspirin, proton pump inhibitor&#xD;
             (PPIs), H2 blocker and antacid in the past 7 days;&#xD;
&#xD;
          -  Contraindication to the use of NSAIDs or PPIs;&#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>
  <overall_official>
    <last_name>Pedro A. Petersen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allergisa Pesquisa Dermato-Cosmetica LTDA</affiliation>
  </overall_official>
  <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>
  <results_reference>
    <citation>Scheinberg M, Pott Junior H, Macedo EA, Bocchi de Oliveira MF, Ecclissato C, Amazonas RB. Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms. Drug Des Devel Ther. 2018 Sep 6;12:2775-2783. doi: 10.2147/DDDT.S172068. eCollection 2018.</citation>
    <PMID>30233140</PMID>
  </results_reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</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>Inflammation</mesh_term>
    <mesh_term>Dyspepsia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naproxen</mesh_term>
    <mesh_term>Nimesulide</mesh_term>
    <mesh_term>Esomeprazole</mesh_term>
    <mesh_term>Pantoprazole</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/NCT01670552
org study id: NIPEMS1111
nct id: NCT01670552
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the safety of an association with one
      anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and
      one gastroprotective agent in patients with acute or chronic osteoarticular inflammation.
-  Double-blind,randomized, multicenter

        -  Experiment duration: 14 days

        -  03 visits

        -  Evaluate the safety of an association with one anti-inflammatory and one
           gastroprotective compared to association with one anti-inflammatory and one
           gastroprotective agent in patients with acute or chronic osteoarticular inflammation

        -  Adverse events evaluation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Comparison relieve pain in patients with osteoarticular diseases and dyspeptic symptoms, defined as visual analogue scale (VAS) version modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
time frame: 14 days
measure: Incidence of adverse events and dyspeptic complaints during the study
time frame: 14 days
arm group label: Nimesulide + Pantoprazole
arm group type: Experimental
description: Nimesulide + Pantoprazole- 1 tablet each 12 hours for 14 days
arm group label: Naproxen + Esomeprazole
arm group type: Active Comparator
description: Naproxen + Esomeprazole - 1 tablet each 12 hours for 14 days
intervention type: Drug
intervention name: Nimesulide + Pantoprazole
description: 1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Naproxen + Esomeprazole placebo.
arm group label: Nimesulide + Pantoprazole
intervention type: Drug
intervention name: Naproxen + Esomeprazole
description: 1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Nimesulide + Pantoprazole placebo.
arm group label: Naproxen + Esomeprazole
other name: VIMOVO
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Pedro A. Petersen, MD
role: Principal Investigator
affiliation: Allergisa Pesquisa Dermato-Cosmetica LTDA
facility: 
country: Brazil
citation: Scheinberg M, Pott Junior H, Macedo EA, Bocchi de Oliveira MF, Ecclissato C, Amazonas RB. Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms. Drug Des Devel Ther. 2018 Sep 6;12:2775-2783. doi: 10.2147/DDDT.S172068. eCollection 2018.
PMID: 30233140
responsible party type: Sponsor
mesh term: Inflammation
mesh term: Dyspepsia
mesh term: Naproxen
mesh term: Nimesulide
mesh term: Esomeprazole
mesh term: Pantoprazole