<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/NCT02184260</url>
  </required_header>
  <id_info>
    <org_study_id>1093.15</org_study_id>
    <nct_id>NCT02184260</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Metamizole Versus Placebo as Antithermic Therapy in the Acute Phase of Ischemic Stroke</brief_title>
  <acronym>ATIS</acronym>
  <official_title>A Randomized, Multicentre, Double-blind Clinical Trial of Metamizole 2 g /8 h, I.V. Ampoules, Versus Placebo Each 8 h, I.V. Ampoules, Administered During 3 Days Consecutively as Antithermic Therapy in the Acute Phase of Ischemic Stroke. A 30-day Study. (ATIS Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Clinical efficacy and safety of Metamizole 2 g i.v. versus placebo, as antithermic therapy in&#xD;
      the acute phase of ischemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>December 1998</start_date>
  <primary_completion_date type="Actual">May 2002</primary_completion_date>
  <phase>Phase 4</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>Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS)</measure>
    <time_frame>after 30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of functional outcome according to SSS</measure>
    <time_frame>Baseline, after 3 and 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with score of SSS &lt; 30 points</measure>
    <time_frame>after 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical impression assessed on the Modified Rankin Scale</measure>
    <time_frame>after 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on the activities of daily living assessed on Barthel Index</measure>
    <time_frame>after 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients requiring rescue therapy</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tympanic temperature</measure>
    <time_frame>up to 3 days after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of mortality</measure>
    <time_frame>after 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Metamizole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metamizole</intervention_name>
    <arm_group_label>Metamizole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  Hemispherical cerebral infarction with moderate (SSS = 30-44 points) or severe (SSS &lt;&#xD;
             30 points) deficit at the time of inclusion. However, only patients with a score&#xD;
             between 15 and 44 points on the SSS scale will be included&#xD;
&#xD;
          -  Tympanic temperature between 37 and 38 degrees Celsius. The relationship between&#xD;
             tympanic and body temperature is as follows: tympanic temperature = body temperature +&#xD;
             0.3 degrees Celsius&#xD;
&#xD;
          -  Onset of cerebral infarction symptoms within the last 24 hours. When the time of onset&#xD;
             of symptoms is unknown (e.g. ictus occurred while sleeping) the last time when the&#xD;
             patient was asymptomatic will be considered as time of onset&#xD;
&#xD;
          -  Normal cerebral CT scan or with signs of cerebral infarction&#xD;
&#xD;
          -  Patient's written or orally witnessed informed consent in accordance with local&#xD;
             legislation, guidelines of Good Clinical Practice (GCP) and International Conference&#xD;
             on Harmonization (ICH)-GCP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of granulocytopenia, thrombocytopenia or aplastic blood&#xD;
             diseases of any etiology. Known hypersensitivity to salicylates, pyrazolones and other&#xD;
             nonsteroidal antiinflammatory drugs (NSAIDs). NSAID-induced bronchial asthma&#xD;
&#xD;
          -  Patients with a history indicating a life expectancy less than 30 days or patients&#xD;
             whom the investigator thinks that it will not be possible to follow for entire 30 days&#xD;
&#xD;
          -  Non-cooperative&#xD;
&#xD;
          -  Patients with neurological sequelae of a previous stroke&#xD;
&#xD;
          -  Cerebral hemorrhage&#xD;
&#xD;
          -  Pregnancy, lactation&#xD;
&#xD;
          -  Participation in another clinical trial&#xD;
&#xD;
          -  Intake of acetylsalicylic acid (ASA) &gt; 300 mg per day, paracetamol or NSAIDs during&#xD;
             the 24 hours prior to administration of the study medication&#xD;
&#xD;
          -  Seizures at the start of the stroke&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1093/1093.15_U04-1020.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 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>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dipyrone</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/NCT02184260
org study id: 1093.15
nct id: NCT02184260
lead sponsor: 
Clinical efficacy and safety of Metamizole 2 g i.v. versus placebo, as antithermic therapy in
      the acute phase of ischemic stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS)
time frame: after 30 days
measure: Assessment of functional outcome according to SSS
time frame: Baseline, after 3 and 7 days
measure: Number of patients with score of SSS < 30 points
time frame: after 30 days
measure: Clinical impression assessed on the Modified Rankin Scale
time frame: after 30 days
measure: Effect on the activities of daily living assessed on Barthel Index
time frame: after 30 days
measure: Number of patients requiring rescue therapy
time frame: up to 30 days
measure: Duration of hospital stay
time frame: up to 30 days
measure: Assessment of tympanic temperature
time frame: up to 3 days after start of treatment
measure: Percentage of mortality
time frame: after 30 days
measure: Number of patients with adverse events
time frame: up to 30 days
arm group label: Metamizole
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Metamizole
arm group label: Metamizole
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1093/1093.15_U04-1020.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Dipyrone