<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/NCT02183220</url>
  </required_header>
  <id_info>
    <org_study_id>1093.16</org_study_id>
    <nct_id>NCT02183220</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerability of Metamizol in Patients With Episodic Moderate Headache</brief_title>
  <official_title>A Randomised, Double Blind, Placebo- and Active-controlled Parallel Group Study Investigating the Efficacy and Tolerability of Metamizol 0.5 g and 1.0 g in Patients With Episodic Moderate Tension Headache.</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 objective of the study was to evaluate the efficacy, safety and tolerability of a single&#xD;
      peroral dose of 0.5 g and 1.0 g metamizol relative to placebo and 1.0 g acetylsalicylic acid&#xD;
      in 2 episodes of moderate tension headache.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 1998</start_date>
  <primary_completion_date type="Actual">July 1999</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>Time-interval weighted sum of pain intensity difference (SPID) on a Visual Analogue Scale (VAS)</measure>
    <time_frame>before and 30 minutes, 1, 2, 3, and 4 hours after drug intake</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity difference (PID) on a VAS</measure>
    <time_frame>before and 30 minutes, 1, 2, 3, and 4 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum pain intensity difference (MAXPID) on a VAS</measure>
    <time_frame>before and 30 minutes, 1, 2, 3, and 4 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with at least a 50% pain reduction on a VAS</measure>
    <time_frame>before and 30 minutes, 1, 2, 3, and 4 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to 50% pain intensity reduction on a VAS</measure>
    <time_frame>before and 30 minutes, 1, 2, 3, and 4 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum pain relief (MAXPAR) on a Verbal Rating Scale (VRS)</measure>
    <time_frame>30 minutes, 1, 2, 3, and 4 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total pain relief (TOTPAR) on a VRS</measure>
    <time_frame>30 minutes, 1, 2, 3, and 4 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients using rescue medication</measure>
    <time_frame>2, 3, and 4 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global efficacy assessment on a VRS by the patient and investigator</measure>
    <time_frame>4 hours after drug intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 2 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">417</enrollment>
  <condition>Migraine Disorders</condition>
  <arm_group>
    <arm_group_label>Metamizol high &amp; Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Metamizol low &amp; Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Acetylsalicylic acid &amp; Placebo</arm_group_label>
    <arm_group_type>Active Comparator</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>Metamizol</intervention_name>
    <arm_group_label>Metamizol high &amp; Placebo</arm_group_label>
    <arm_group_label>Metamizol low &amp; Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetylsalicylic acid (ASA)</intervention_name>
    <arm_group_label>Acetylsalicylic acid &amp; Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metamizol placebo</intervention_name>
    <arm_group_label>Metamizol high &amp; Placebo</arm_group_label>
    <arm_group_label>Metamizol low &amp; Placebo</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASA placebo</intervention_name>
    <arm_group_label>Acetylsalicylic acid &amp; Placebo</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients between 18 and 65 years old&#xD;
&#xD;
          -  Moderate episodic tension headache according to International Headache Society&#xD;
             (I.H.S.) classification 2.1 (2.1.1 and 2.1.2) for at least one year&#xD;
&#xD;
          -  At least two episodes of tension headache per month in the last three months prior to&#xD;
             enrolment into this trial&#xD;
&#xD;
          -  The episodes of tension headaches were usually treated by the patient successfully&#xD;
             with a non-opioid-analgesic&#xD;
&#xD;
          -  First episodic headache occurred at an age under 50 years&#xD;
&#xD;
          -  Written informed consent according to Good Clinical Practice (GCP) and local&#xD;
             regulations&#xD;
&#xD;
          -  The patient was able to fill in the Patient's Diary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient usually needs for successful treatment of tension headache &quot;Over The&#xD;
             Counter&quot; (OTC) analgesic in doses exceeding the doses tested here&#xD;
&#xD;
          -  The patient takes an OTC-analgesic normally at the first signs of an episode of&#xD;
             tension headache&#xD;
&#xD;
          -  The patient has more than 15 episodes of tension headache per month&#xD;
&#xD;
          -  Female patients whose episodic tension headache is strongly correlated with the start&#xD;
             of hormonal contraception&#xD;
&#xD;
          -  Concomitant treatment with (non-) prescriptional analgesics&#xD;
&#xD;
          -  Pre- (less than 4 weeks prior to inclusion in this trial) and/or concomitant treatment&#xD;
             with an antidepressive and/or antipsychotic drug&#xD;
&#xD;
          -  Pre- (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment&#xD;
             with any drug such as NSAIDs (Non-Steroidal Anti Inflammatory Drugs), propanolol,&#xD;
             metroprolol, flunarizin, cyclandelate, valproic-acid, serotonergic antagonists,&#xD;
             ergotamine, dihydroergotamines and benzodiazepines that may influence the headache&#xD;
             symptomatology&#xD;
&#xD;
          -  Use of benzodiazepines in the previous 24 hours to the administration of the study&#xD;
             drug. Occasional use of benzodiazepines - up to 3 per week - is allowed&#xD;
&#xD;
          -  Use of any drug with analgesic properties in the previous 24 hours to the&#xD;
             administration of the study drug&#xD;
&#xD;
          -  Concomitant treatment with any drug containing ASA and/or metamizol&#xD;
&#xD;
          -  Concomitant treatment with anticoagulants such as heparin or coumarin-derivatives&#xD;
&#xD;
          -  Alcohol and drug abuse according to DSM-IV (Diagnostic and Statistical Manual of&#xD;
             Mental Disorders )&#xD;
&#xD;
          -  Female patients in child-bearing age not using adequate means of birth control&#xD;
&#xD;
          -  Pregnancy and/or lactation&#xD;
&#xD;
          -  Gastrointestinal ulcers&#xD;
&#xD;
          -  Liver and/or renal disease&#xD;
&#xD;
          -  Bronchial asthma&#xD;
&#xD;
          -  Relevant allergy or known hypersensitivity to the investigational drugs, its&#xD;
             excipients and/or to other NSAIDs&#xD;
&#xD;
          -  Participation in another clinical trial within the last 4 weeks and concurrent&#xD;
             participation in another clinical trial&#xD;
&#xD;
          -  Patients with active gastroesophageal flux disease (Amendment number 1)&#xD;
&#xD;
          -  Concomitant treatment with analgesics or any other drug that may have influenced the&#xD;
             headache symptomatology - including metamizol or ASA -, was referred to its use during&#xD;
             the headache episodes under evaluation. As long as appropriate wash-out periods were&#xD;
             respected, analgesics were allowed in between the episodes of tension headache (TH)&#xD;
             and their use as a rescue medication did not lead to the exclusion of the patient&#xD;
             (Amendment number 2)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1093/1093.16_U00-0018.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 4, 2014</last_update_submitted>
  <last_update_submitted_qc>July 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 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>Migraine Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <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/NCT02183220
org study id: 1093.16
nct id: NCT02183220
lead sponsor: 
The objective of the study was to evaluate the efficacy, safety and tolerability of a single
      peroral dose of 0.5 g and 1.0 g metamizol relative to placebo and 1.0 g acetylsalicylic acid
      in 2 episodes of moderate tension headache.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Time-interval weighted sum of pain intensity difference (SPID) on a Visual Analogue Scale (VAS)
time frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
measure: Pain intensity difference (PID) on a VAS
time frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
measure: Maximum pain intensity difference (MAXPID) on a VAS
time frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
measure: Number of patients with at least a 50% pain reduction on a VAS
time frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
measure: Time to 50% pain intensity reduction on a VAS
time frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
measure: Maximum pain relief (MAXPAR) on a Verbal Rating Scale (VRS)
time frame: 30 minutes, 1, 2, 3, and 4 hours after drug intake
measure: Total pain relief (TOTPAR) on a VRS
time frame: 30 minutes, 1, 2, 3, and 4 hours after drug intake
measure: Number of patients using rescue medication
time frame: 2, 3, and 4 hours after drug intake
measure: Global efficacy assessment on a VRS by the patient and investigator
time frame: 4 hours after drug intake
measure: Number of patients with adverse events
time frame: up to 2 months
arm group label: Metamizol high & Placebo
arm group type: Experimental
arm group label: Metamizol low & Placebo
arm group type: Experimental
arm group label: Acetylsalicylic acid & Placebo
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Metamizol
arm group label: Metamizol high & Placebo
arm group label: Metamizol low & Placebo
intervention type: Drug
intervention name: Acetylsalicylic acid (ASA)
arm group label: Acetylsalicylic acid & Placebo
intervention type: Drug
intervention name: Metamizol placebo
arm group label: Metamizol high & Placebo
arm group label: Metamizol low & Placebo
arm group label: Placebo
intervention type: Drug
intervention name: ASA placebo
arm group label: Acetylsalicylic acid & Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1093/1093.16_U00-0018.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Headache
mesh term: Aspirin
mesh term: Dipyrone