<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/NCT02199847</url>
  </required_header>
  <id_info>
    <org_study_id>1114.11</org_study_id>
    <nct_id>NCT02199847</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effects of Pharmaton Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shift</brief_title>
  <official_title>An Evaluation of the Effects of Pharmaton® Caplets Film-coated Tablets on Mental Performance and Physical Fatigue in Nurses Working Night Shifts: a Double-blind, Placebo Controlled Pilot Trial</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 general aim of this study is to assess the effects of Pharmaton® Caplets on mental&#xD;
      performance and physical fatigue in nurses and nursing auxiliaries working night shifts&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2000</start_date>
  <primary_completion_date type="Actual">January 2001</primary_completion_date>
  <phase>Phase 2</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>Change from baseline in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram (EEG) (post-shift)</measure>
    <time_frame>at day 77</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram)</measure>
    <time_frame>up to day 77</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of spontaneous Electroencephalogram (EEG) and event related potentials</measure>
    <time_frame>up to day 77</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Sleep-Electroencephalogram parameters</measure>
    <time_frame>Day -1, Day 1, Day 77</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Quality of life scales</measure>
    <time_frame>up to day 77</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Sleep by Visual Analogue Scale (VAS)</measure>
    <time_frame>up to day 77</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of 24-hours holter Electrocardiogram (ECG)</measure>
    <time_frame>Day -1, Day1, Day 77</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of urinary cortisol levels</measure>
    <time_frame>Day -1, Day1, Day 77</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>at day 77</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by subject on a 4-point scale</measure>
    <time_frame>Day 41, Day 77</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Sleep Disorders, Circadian Rhythm</condition>
  <arm_group>
    <arm_group_label>Pharmaton® Caplets</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>Pharmaton® Caplets</intervention_name>
    <arm_group_label>Pharmaton® Caplets</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;
          -  Male and female nurses and nursing auxiliaries working night shift&#xD;
&#xD;
          -  Age range: 20 to 45 inclusive&#xD;
&#xD;
          -  BMI range: 18-30&#xD;
&#xD;
          -  Negative pregnancy test for females&#xD;
&#xD;
          -  Subjects must be free of any clinically significant disease or condition that required&#xD;
             a physician's care and/or was to interfere with study evaluation and procedures&#xD;
&#xD;
          -  Clinical laboratory tests within normal limits or, if out of normal range, clinically&#xD;
             acceptable to the investigator&#xD;
&#xD;
          -  Negative urine drug screen for drugs at screening&#xD;
&#xD;
          -  Subjects must be willing to give informed consent prior to study enrolment and be able&#xD;
             to adhere to restrictions and examination schedules&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any serious disorder that may interfere with his/her participation to the trial and&#xD;
             the evaluation of the safety of the test drug (e.g. liver and/or renal disease,&#xD;
             hypervitaminosis A, psychic disorder, etc.) and/or treatment with chronic medication&#xD;
&#xD;
          -  Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant&#xD;
             treatment with any drug that may influence the trial symptomatology and may interfere&#xD;
             with evaluation of the safety of the test drug (e.g. vitamins and minerals&#xD;
             supplementation)&#xD;
&#xD;
          -  Individuals drinking more than 40 g alcohol/day (glass of 12.5 cl of wine 10° = 12 g;&#xD;
             glass of 4 cl of aperitif 42° = 17 g; glass of 25 cl of beer 3° = 7.5 g; glass of 25&#xD;
             cl of beer 6° = 15 g); Alcohol and drug abuse according to Diagnostic and Statistic&#xD;
             Manual, Version IV (DSM-IV)&#xD;
&#xD;
          -  Individuals drinking more that 6 cups of coffee or tea/day&#xD;
&#xD;
          -  Individuals smoking more than 10 cigarettes/day&#xD;
&#xD;
          -  Female volunteers in child-bearing age not using adequate means of birth control&#xD;
             (contraceptive pills, Intrauterine Device (IUD), sterilization)&#xD;
&#xD;
          -  Pregnancy and/or lactation&#xD;
&#xD;
          -  Relevant allergy or known hypersensitivity to the investigational product or its&#xD;
             excipients&#xD;
&#xD;
          -  Individuals taking or having taken recently other vitamins and minerals&#xD;
             supplementation&#xD;
&#xD;
          -  Individuals with a current disorder likely to modify EEG recordings and/or&#xD;
             computerized cognitive testing&#xD;
&#xD;
          -  Individuals having a history of cancer&#xD;
&#xD;
          -  Participation in another clinical trial within the last 3 months prior to the start of&#xD;
             the study and concurrent participation in another clinical trial&#xD;
&#xD;
          -  Individuals without health insurance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 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>Sleep Wake Disorders</mesh_term>
    <mesh_term>Sleep Disorders, Circadian Rhythm</mesh_term>
  </condition_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/NCT02199847
org study id: 1114.11
nct id: NCT02199847
lead sponsor: 
The general aim of this study is to assess the effects of Pharmaton® Caplets on mental
      performance and physical fatigue in nurses and nursing auxiliaries working night shifts
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Change from baseline in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram (EEG) (post-shift)
time frame: at day 77
measure: Change in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram)
time frame: up to day 77
measure: Assessment of spontaneous Electroencephalogram (EEG) and event related potentials
time frame: up to day 77
measure: Assessment of Sleep-Electroencephalogram parameters
time frame: Day -1, Day 1, Day 77
measure: Evaluation of Quality of life scales
time frame: up to day 77
measure: Evaluation of Sleep by Visual Analogue Scale (VAS)
time frame: up to day 77
measure: Assessment of 24-hours holter Electrocardiogram (ECG)
time frame: Day -1, Day1, Day 77
measure: Assessment of urinary cortisol levels
time frame: Day -1, Day1, Day 77
measure: Number of patients with adverse events
time frame: up to 3 months
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: at day 77
measure: Assessment of tolerability by subject on a 4-point scale
time frame: Day 41, Day 77
arm group label: Pharmaton® Caplets
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Pharmaton® Caplets
arm group label: Pharmaton® Caplets
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Sleep Wake Disorders
mesh term: Sleep Disorders, Circadian Rhythm