<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/NCT02189239</url>
  </required_header>
  <id_info>
    <org_study_id>Ze 185-4-2014-02</org_study_id>
    <nct_id>NCT02189239</nct_id>
  </id_info>
  <brief_title>Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress</brief_title>
  <official_title>A Phase IV, Randomised, Placebo Controlled Study to Investigate the Effects of Zeller Entspannung Film Coated Tablets on Cortisol Responses in Healthy Volunteers With Acute Stress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Max Zeller Soehne AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Max Zeller Soehne AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the STRESS trial is to investigate in a mode of action setting the effect of&#xD;
      Zeller Entspannung film coated tablets on saliva cortisol response versus Placebo after acute&#xD;
      stress in healthy male volunteers. In addition, data on safety and tolerability of Zeller&#xD;
      Entspannung will be obtained.&#xD;
&#xD;
      A third arm including no treatment is tested as well. Approximately 72 healthy volunteers&#xD;
      will be included into this randomized, double blind study. Study duration will be 7 days,&#xD;
      study medication intake will be over 4 days: participants will take the medication one tablet&#xD;
      three times a day (morning, midday, evening) the first 3 days, whereas on day 4 only two&#xD;
      tablets will be taken (morning and midday).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary objective is to demonstrate in healthy male volunteers that Zeller Entspannung reduces overall saliva cortisol level (AUCg) after acute stress compared with a placebo.</measure>
    <time_frame>4 days</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>The Primary Condition Studied for This Trial is Acute Stress</condition>
  <arm_group>
    <arm_group_label>Zeller Entspannung film coated tablets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Relaxing film coated tablets, 570 mg (Zeller Entspannung Filmtabletten), 3x1 tablet per day for the first three days (morning, midday, evening), at day four 2x1 tablet (morning, midday) preferably during meals with a glass of water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo tablets</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo medication is identical in presentation, color and shape, 3x1 tablet per day for the first three days (morning, midday, evening), at day four 2x1 tablet (morning, midday) during meals with a glass of water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>No medication intake.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zeller Entspannung film coated tablet</intervention_name>
    <arm_group_label>Zeller Entspannung film coated tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Treatment</intervention_name>
    <arm_group_label>No Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age:18 - 45 years&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Male gender&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any acute or chronic somatic or psychiatric disorder&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Any clinically relevant hepatic disorder&#xD;
&#xD;
          -  Any clinically relevant renal disorder&#xD;
&#xD;
          -  Any clinically relevant cardiac disorder&#xD;
&#xD;
          -  Any clinically relevant respiratory disease (e.g. Asthma)&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Any abnormal lab values suggesting diseases from exclusion criteria&#xD;
&#xD;
          -  Known allergies to trial medication and excipients&#xD;
&#xD;
          -  Alcohol or other drug abuse (e.g. cannabis)&#xD;
&#xD;
          -  Concomitant participation in another clinical trial or &lt;4 weeks ago&#xD;
&#xD;
          -  Participation in any psychotherapy&#xD;
&#xD;
          -  Already participated in a TSST&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Phase I Research Unit, University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2015</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 14, 2014</study_first_posted>
  <last_update_submitted>June 24, 2015</last_update_submitted>
  <last_update_submitted_qc>June 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02189239
org study id: Ze 185-4-2014-02
nct id: NCT02189239
lead sponsor: 
has dmc: No
The objective of the STRESS trial is to investigate in a mode of action setting the effect of
      Zeller Entspannung film coated tablets on saliva cortisol response versus Placebo after acute
      stress in healthy male volunteers. In addition, data on safety and tolerability of Zeller
      Entspannung will be obtained.

      A third arm including no treatment is tested as well. Approximately 72 healthy volunteers
      will be included into this randomized, double blind study. Study duration will be 7 days,
      study medication intake will be over 4 days: participants will take the medication one tablet
      three times a day (morning, midday, evening) the first 3 days, whereas on day 4 only two
      tablets will be taken (morning and midday).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The primary objective is to demonstrate in healthy male volunteers that Zeller Entspannung reduces overall saliva cortisol level (AUCg) after acute stress compared with a placebo.
time frame: 4 days
arm group label: Zeller Entspannung film coated tablets
arm group type: Active Comparator
description: Relaxing film coated tablets, 570 mg (Zeller Entspannung Filmtabletten), 3x1 tablet per day for the first three days (morning, midday, evening), at day four 2x1 tablet (morning, midday) preferably during meals with a glass of water.
arm group label: Placebo tablets
arm group type: Placebo Comparator
description: Placebo medication is identical in presentation, color and shape, 3x1 tablet per day for the first three days (morning, midday, evening), at day four 2x1 tablet (morning, midday) during meals with a glass of water.
arm group label: No Treatment
arm group type: Sham Comparator
description: No medication intake.
intervention type: Drug
intervention name: Zeller Entspannung film coated tablet
arm group label: Zeller Entspannung film coated tablets
intervention type: Drug
intervention name: Placebo
arm group label: Placebo tablets
intervention type: Other
intervention name: No Treatment
arm group label: No Treatment
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor