<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/NCT02183233</url>
  </required_header>
  <id_info>
    <org_study_id>1120.2</org_study_id>
    <nct_id>NCT02183233</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia</brief_title>
  <official_title>A Double-blind Randomized, Placebo Controlled Study to Assess the Efficacy and the Safety of Eschscholtzia Californica 1000 mg Per Day in Treating Primary Insomnia During a 28 Day Treatment Duration.</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 aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica (EC)&#xD;
      in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo&#xD;
      controlled trial during a 28-day treatment duration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>January 1998</start_date>
  <primary_completion_date type="Actual">June 1998</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>Change from baseline in sleep latency</measure>
    <time_frame>Days 0, 7, 14 and 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in sleep duration</measure>
    <time_frame>Days 0, 7, 14 and 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in number of awakenings</measure>
    <time_frame>Days 0, 7, 14 and 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in quality of sleep</measure>
    <time_frame>Days 0, 7, 14 and 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in presence of morning sleepiness</measure>
    <time_frame>Days 0, 7, 14 and 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in morning concentration ability</measure>
    <time_frame>Days 0, 7, 14 and 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Clinical Global Impression (CGI) score</measure>
    <time_frame>Days 0, 7, 14 and 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in quality of life (QL questionnaire SF-23)</measure>
    <time_frame>Days 0, 7, 14 and 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Sleep Initiation and Maintenance Disorders</condition>
  <arm_group>
    <arm_group_label>Eschscholtzia Californica</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Eschscholtzia Californica Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eschscholtzia Californica</intervention_name>
    <arm_group_label>Eschscholtzia Californica</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eschscholtzia Californica Placebo</intervention_name>
    <arm_group_label>Eschscholtzia Californica Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female above 18 or below 65 years old&#xD;
&#xD;
          -  Diagnosis of psycho-physiologic insomnia, according to the criteria of DSM-IV&#xD;
             (Diagnostic and Statistical manual - Version IV)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who is already taking other investigational drugs or who has taken part in&#xD;
             another trial during the past three months&#xD;
&#xD;
          -  Patient who has an history of psychiatric diseases, such as:&#xD;
&#xD;
               -  anxiety disorders; the score of the HAMA (Hamilton anxiety scale) must be &lt; 10&#xD;
&#xD;
               -  depression according to the DSM IV criteria; the score of the HAMD (Hamilton&#xD;
                  depression scale) must be &lt; 10&#xD;
&#xD;
               -  mania&#xD;
&#xD;
               -  schizophrenia&#xD;
&#xD;
               -  dementia&#xD;
&#xD;
          -  Patient who has an history of neurologic diseases, such as:&#xD;
&#xD;
               -  Parkinson syndrome&#xD;
&#xD;
               -  crania cerebral trauma post syndrome&#xD;
&#xD;
               -  brain tumor&#xD;
&#xD;
               -  fibromyalgia&#xD;
&#xD;
          -  Patient who has an history of an iatrogenic insomnia, due to drugs like antidepressor,&#xD;
             neuroleptic or benzodiazepine, hypnotic&#xD;
&#xD;
          -  Patient with an hypersomnia or a sleep apnea syndrome&#xD;
&#xD;
          -  Patient with any pathology inducing a chronic pain, a pyrosis, a nocturnal&#xD;
             pollakiuria, a dyspnea&#xD;
&#xD;
          -  Patient with a Restless Leg Syndrome&#xD;
&#xD;
          -  Patient with severe hepatic or renal insufficiency which judged to be regarded as&#xD;
             clinically relevant by the investigator, or any known clinically significant disease&#xD;
             which may induce a risk for the patient in participating to the trial&#xD;
&#xD;
          -  Breast feeding or pregnant female, or female with no efficient contraception method&#xD;
&#xD;
          -  Patient with non-stabilised thyroid dysfunction&#xD;
&#xD;
          -  Patient with a known allergy to Eschscholtzia Californica or its compounds&#xD;
&#xD;
          -  Patient with alcohol or drug dependency&#xD;
&#xD;
          -  Patient drinking tea, coffee or Coca-Cola after 4 p.m.&#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/1120/1120.2_U99-0189.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>Sleep Initiation and Maintenance Disorders</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/NCT02183233
org study id: 1120.2
nct id: NCT02183233
lead sponsor: 
The aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica (EC)
      in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo
      controlled trial during a 28-day treatment duration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Change from baseline in sleep latency
time frame: Days 0, 7, 14 and 28
measure: Change from baseline in sleep duration
time frame: Days 0, 7, 14 and 28
measure: Change from baseline in number of awakenings
time frame: Days 0, 7, 14 and 28
measure: Change from baseline in quality of sleep
time frame: Days 0, 7, 14 and 28
measure: Change from baseline in presence of morning sleepiness
time frame: Days 0, 7, 14 and 28
measure: Change from baseline in morning concentration ability
time frame: Days 0, 7, 14 and 28
measure: Change from baseline in Clinical Global Impression (CGI) score
time frame: Days 0, 7, 14 and 28
measure: Change from baseline in quality of life (QL questionnaire SF-23)
time frame: Days 0, 7, 14 and 28
measure: Number of patients with adverse events
time frame: up to 28 days
arm group label: Eschscholtzia Californica
arm group type: Experimental
arm group label: Eschscholtzia Californica Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Eschscholtzia Californica
arm group label: Eschscholtzia Californica
intervention type: Drug
intervention name: Eschscholtzia Californica Placebo
arm group label: Eschscholtzia Californica 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/1120/1120.2_U99-0189.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders