<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/NCT02184351</url>
  </required_header>
  <id_info>
    <org_study_id>1190.1</org_study_id>
    <nct_id>NCT02184351</nct_id>
  </id_info>
  <brief_title>Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis</brief_title>
  <official_title>A Prospective Randomized, Blinded Parallel Group Study of Clotrimazole Troches vs. Mycelex® Troches (10 mg Troche Five Times a Day for 14 Days) in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis</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 objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole&#xD;
      troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where&#xD;
      this condition has been diagnosed by clinical examination and confirmed by fungal culture.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2001</start_date>
  <primary_completion_date type="Actual">November 2001</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>Single</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of patients that have a clinical response assessed by symptoms and physical examination</measure>
    <time_frame>Day 21</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of negative fungal cultures of the oropharynx for Candida species</measure>
    <time_frame>7 days after end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of negative fungal cultures of the oropharynx for Candida species</measure>
    <time_frame>after 14 days of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response by symptom assessment and physical examination</measure>
    <time_frame>after 7 and 14 days of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of compliance with Treatment by troche Count and Patient interview</measure>
    <time_frame>after 7 and 14 days of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">187</enrollment>
  <condition>Candidiasis, Oral</condition>
  <arm_group>
    <arm_group_label>Roxanes's clotrimazole troches</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Mycelex® troches</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Roxanes's clotrimazole troches</intervention_name>
    <arm_group_label>Roxanes's clotrimazole troches</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycelex® troches</intervention_name>
    <arm_group_label>Mycelex® troches</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented HIV positive status&#xD;
&#xD;
          -  Clinical examination of oropharynx is consistent with diagnosis of oral Candidiasis&#xD;
             (such as creamy, white, curdlike patches or erythematous lesions on mucosal surfaces)&#xD;
&#xD;
          -  Findings on direct microscopic examination (Gram Stain or potassium hydroxide smear)&#xD;
             consistent with Candida species or positive fungal culture for Candida species, with&#xD;
             culture obtained in the 2 days preceding initiation of therapy with the study drug&#xD;
&#xD;
          -  Male or female patients ≥ 18 years&#xD;
&#xD;
          -  For women of childbearing potential: negative blood or urine pregnancy test and&#xD;
             agreement to use adequate contraception (investigator's discretion) while on study&#xD;
             drug&#xD;
&#xD;
          -  Mental status allows comprehension of instructions for troche administration&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sings of symptoms suggestive of esophageal Candidiasis (such as dysphagia or&#xD;
             odynophagia) unless the results of an endoscopic evaluation of the esophagus are&#xD;
             negative&#xD;
&#xD;
          -  Presence of perioral lesions only&#xD;
&#xD;
          -  Use of other antifungal agents within 5 days of enrollment to the study&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  History of hypersensitivity to imidazole or azole compounds&#xD;
&#xD;
          -  Patient unwilling or unable to be followed at the study center for the duration of the&#xD;
             study (3 weeks)&#xD;
&#xD;
          -  Patients has received an investigational drug in the last 30 days&#xD;
&#xD;
          -  Treatment with another investigational drug is planned within the next 3 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1190/1190.1_U02-3190.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Candidiasis</mesh_term>
    <mesh_term>Candidiasis, Oral</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clotrimazole</mesh_term>
    <mesh_term>Miconazole</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/NCT02184351
org study id: 1190.1
nct id: NCT02184351
lead sponsor: 
The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole
      troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where
      this condition has been diagnosed by clinical examination and confirmed by fungal culture.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single
measure: Percent of patients that have a clinical response assessed by symptoms and physical examination
time frame: Day 21
measure: Incidence of negative fungal cultures of the oropharynx for Candida species
time frame: 7 days after end of treatment
measure: Incidence of negative fungal cultures of the oropharynx for Candida species
time frame: after 14 days of treatment
measure: Clinical response by symptom assessment and physical examination
time frame: after 7 and 14 days of treatment
measure: Assessment of compliance with Treatment by troche Count and Patient interview
time frame: after 7 and 14 days of treatment
arm group label: Roxanes's clotrimazole troches
arm group type: Experimental
arm group label: Mycelex® troches
arm group type: Active Comparator
intervention type: Drug
intervention name: Roxanes's clotrimazole troches
arm group label: Roxanes's clotrimazole troches
intervention type: Drug
intervention name: Mycelex® troches
arm group label: Mycelex® troches
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1190/1190.1_U02-3190.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Candidiasis
mesh term: Candidiasis, Oral
mesh term: Clotrimazole
mesh term: Miconazole