<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/NCT02187562</url>
  </required_header>
  <id_info>
    <org_study_id>107.255</org_study_id>
    <nct_id>NCT02187562</nct_id>
  </id_info>
  <brief_title>Effect of Steady State Meloxicam on Low Dose Aspirin Induced Inhibition of Platelet Aggregation and Thromboxane Synthesis in Healthy Males and Females</brief_title>
  <official_title>Effect of Steady State Meloxicam 15 mg/Day on Low Dose Aspirin (100 mg/Day) Induced Inhibition of Platelet Aggregation and Thromboxane Synthesis in Healthy Males and Females. An Open, Randomised, Two-way Crossover 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>
      The objective of this study was to investigate the influence of meloxicam on low dose aspirin&#xD;
      induced inhibition of platelet aggregation and thromboxane B2, when meloxicam is given before&#xD;
      aspirin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2002</start_date>
  <primary_completion_date type="Actual">August 2002</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Arachidonic acid induced platelet aggregation</measure>
    <time_frame>up to day 11 (treatment 1), up to day 3 (treatment 2)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Collagen-induced Platelet Aggregation</measure>
    <time_frame>up to day 11 (treatment 1), up to day 3 (treatment 2)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adenosine diphosphate (ADP) Induced Platelet Aggregation</measure>
    <time_frame>up to day 11 (treatment 1), up to day 3 (treatment 2)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Thromboxane B2 production</measure>
    <time_frame>up to day 11 (treatment 1), up to day 3 (treatment 2)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>up to day 11 (treatment 1), up to day 3 (treatment 2)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)</measure>
    <time_frame>Screening, 24 hours after the last Aspirin intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs</measure>
    <time_frame>Screening, 24 hours after the last Aspirin intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability on a 4-point scale</measure>
    <time_frame>24 hours after the last Aspirin intake</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Meloxicam/Aspirin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Meloxicam days 1-10 / Aspirin days 5-10</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aspirin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aspirin 2 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meloxicam</intervention_name>
    <arm_group_label>Meloxicam/Aspirin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <arm_group_label>Aspirin</arm_group_label>
    <arm_group_label>Meloxicam/Aspirin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female subjects as determined by results of screening&#xD;
&#xD;
          -  Signed written informed consent in accordance with Good Clinical Practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  Age &gt;=18 and &lt;= 60 years&#xD;
&#xD;
          -  The Body Mass Index (BMI) ≥ 18.5 kg/m2 (square meters) and ≤ 29.9 kg/m2.&#xD;
&#xD;
          -  Laboratory values within a clinical normal range&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and&#xD;
             electrocardiogram (ECG)) deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Surgery of the gastro-intestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) (&lt; 1 month prior to administration&#xD;
             or during the trial)&#xD;
&#xD;
          -  Use of any drugs, which might influence the results of the trial, in particular&#xD;
             aspirin containing drugs(&lt; 14 days prior to administration or during the trial)&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (&lt; 1 months prior to&#xD;
             administration (at least 10 times the relevant elimination half-life) or during trial)&#xD;
&#xD;
          -  Having had prescription medication 2 weeks prior to study drug administration or over&#xD;
             the counter medication 1 week prior to study drug administration (at least 10 times&#xD;
             the relevant elimination half-life)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or 3 cigars or 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 grams (g)/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation or loss &gt; 400 mL (&lt; 1 month prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Excessive physical activities (&lt; 5 days prior to administration or during the trial)&#xD;
&#xD;
          -  Any ECG value outside of the reference range of clinical relevance including, but not&#xD;
             limited to QTcB &gt; 480 ms or QRS interval &gt; 110 ms&#xD;
&#xD;
          -  History of any familial bleeding disorder&#xD;
&#xD;
          -  History of haemorrhagic diatheses&#xD;
&#xD;
          -  History of gastrointestinal ulcer, perforation or bleeding&#xD;
&#xD;
          -  History of bronchial asthma&#xD;
&#xD;
          -  Inability to comply with dietary regimen of study centre&#xD;
&#xD;
          -  Inability to comply with investigator's instructions&#xD;
&#xD;
        For female subjects:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  No adequate contraception (e.g. sterilisation, intrauterine device (IUP), oral&#xD;
             contraceptives)&#xD;
&#xD;
          -  Inability to maintain this adequate contraception during the whole study period&#xD;
&#xD;
          -  Lactation period&#xD;
&#xD;
        Ovarian hormone substitution and oral contraception have to be continued during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.255_U03-1294.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Meloxicam</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/NCT02187562
org study id: 107.255
nct id: NCT02187562
lead sponsor: 
The objective of this study was to investigate the influence of meloxicam on low dose aspirin
      induced inhibition of platelet aggregation and thromboxane B2, when meloxicam is given before
      aspirin.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Arachidonic acid induced platelet aggregation
time frame: up to day 11 (treatment 1), up to day 3 (treatment 2)
measure: Collagen-induced Platelet Aggregation
time frame: up to day 11 (treatment 1), up to day 3 (treatment 2)
measure: Adenosine diphosphate (ADP) Induced Platelet Aggregation
time frame: up to day 11 (treatment 1), up to day 3 (treatment 2)
measure: Serum Thromboxane B2 production
time frame: up to day 11 (treatment 1), up to day 3 (treatment 2)
measure: Number of patients with adverse events
time frame: up to 6 weeks
measure: Number of patients with abnormal changes in laboratory parameters
time frame: up to day 11 (treatment 1), up to day 3 (treatment 2)
measure: Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)
time frame: Screening, 24 hours after the last Aspirin intake
measure: Number of patients with clinically significant changes in vital signs
time frame: Screening, 24 hours after the last Aspirin intake
measure: Assessment of tolerability on a 4-point scale
time frame: 24 hours after the last Aspirin intake
arm group label: Meloxicam/Aspirin
arm group type: Experimental
description: Meloxicam days 1-10 / Aspirin days 5-10
arm group label: Aspirin
arm group type: Active Comparator
description: Aspirin 2 days
intervention type: Drug
intervention name: Meloxicam
arm group label: Meloxicam/Aspirin
intervention type: Drug
intervention name: Aspirin
arm group label: Aspirin
arm group label: Meloxicam/Aspirin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.255_U03-1294.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Aspirin
mesh term: Meloxicam