<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/NCT01697826</url>
  </required_header>
  <id_info>
    <org_study_id>ND1210132-34</org_study_id>
    <secondary_id>CTRI/2011/04/001698</secondary_id>
    <nct_id>NCT01697826</nct_id>
  </id_info>
  <brief_title>Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections</brief_title>
  <official_title>A Comparative Open Labeled Clinical Study to Evaluate the Efficacy and Tolerability of Two Different Intravaginal Formulations Containing a Combination of Clindamycin and Clotrimazole in Vaginal Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Bharti Daswani</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Resilient Cosmeceuticals Pvt. Ltd, Pune</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Daswani, Bhart, M.D.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability&#xD;
      of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate&#xD;
      equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective&#xD;
      vaginitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  This is a Randomized, Comparative, Prospective, Open label, Single center study to&#xD;
           compare the 3 day treatment course of intravaginal soft gelatin capsule containing&#xD;
           clindamycin and clotrimazole versus intravaginal ER tablets of clindamycin and&#xD;
           clotrimazole in patients with vaginal discharge and clinical diagnosis of bacterial,&#xD;
           trichomonal, candidal or mixed vaginitis with respect to efficacy and tolerability; and&#xD;
           to study the in vitro drug release pattern of intravaginal soft gelatin capsule and&#xD;
           intravaginal ER tablets containing clindamycin and clotrimazole.&#xD;
&#xD;
        -  The study will be conducted in B.J. Medical College &amp; Sassoon General Hospitals, Pune.&#xD;
           The study will be completed in 60 patients [30 patients in each group].&#xD;
&#xD;
        -  The primary outcome measure is absence of any clinical sign suggestive of infective&#xD;
           vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal&#xD;
           vaginitis at 8th day after start of treatment [Effectiveness in inducing a remission].&#xD;
&#xD;
        -  The secondary outcome measures will be&#xD;
&#xD;
             1. absence of any clinical sign suggestive of infective vaginitis and&#xD;
&#xD;
             2. a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at&#xD;
                29th day after start of treatment [Effectiveness in maintaining a remission] and&#xD;
                ability to complete the 3day course without any break or experiencing intolerable&#xD;
                side effects [Tolerability].&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary outcome measure for Global effectiveness</measure>
    <time_frame>On 8th day after start of treatment</time_frame>
    <description>Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary outcome measures for Global effectiveness</measure>
    <time_frame>29th day after initiation of treatment</time_frame>
    <description>Number of patients showing absence of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial,trichomonal or candidal vaginitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary outcome measures for tolerability</measure>
    <time_frame>8th day after start of treatment</time_frame>
    <description>Number of patients that are able to successfully complete the 3 day treatment course without a break or experiencing intolerable side-effects</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical Response</measure>
    <time_frame>at 8th day and 29th day after initiation of treatment</time_frame>
    <description>Number of the patients showing normalization of vaginal pH to 4.5</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical response</measure>
    <time_frame>at 8th and 29th day after start of treatment</time_frame>
    <description>Number of the patients achieving improvement in scores for quantity of vaginal discharge by at least 1 unit from baseline</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical response</measure>
    <time_frame>at 8th day and 29th day after start of treatment</time_frame>
    <description>Number of the patients achieving improvement in scores for itching by at least 1 unit from baseline</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Vaginal Infections</condition>
  <arm_group>
    <arm_group_label>ClinSupV3 -soft gelatin capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Soft gelatin capsule containing 100mg Clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ClinSupV3ER- Extended release tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ER tablets containing 100mg clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ClinSupV3 -soft gelatin capsule</intervention_name>
    <description>3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole</description>
    <arm_group_label>ClinSupV3 -soft gelatin capsule</arm_group_label>
    <other_name>Clindamycin plus Clotrimazole</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ClinSupV3ER- Extended release tablet</intervention_name>
    <description>3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole</description>
    <arm_group_label>ClinSupV3ER- Extended release tablet</arm_group_label>
    <other_name>Clindamycin plus Clotrimazole</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with symptoms of vaginal discharge and/or odor and a clinical diagnosis of&#xD;
             vaginitis of infective origin [based on symptoms and signs on per speculum&#xD;
             examination]&#xD;
&#xD;
          -  Age at least 18 years&#xD;
&#xD;
          -  Capable of giving written informed consent&#xD;
&#xD;
          -  Agree to no intercourse for 8 days from the day of start of treatment&#xD;
&#xD;
          -  Agree not to douche or use any intravaginal products during the study period&#xD;
             (including tampons, medications and devices)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Post-menopausal women&#xD;
&#xD;
          -  Menstruating at diagnosis&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any antifungal or antibiotic use 14 days prior to enrolment&#xD;
&#xD;
          -  Use of oral or intravaginal antibiotics within the past 2 weeks&#xD;
&#xD;
          -  Immunosuppressive drug within 4 months&#xD;
&#xD;
          -  Presence of vaginal / vulval ulcer&#xD;
&#xD;
          -  Presence of any other vulval, vaginal or medical condition, including cervical&#xD;
             neoplasia/ treatment that might confound treatment response&#xD;
&#xD;
          -  Inability to keep return appointments&#xD;
&#xD;
          -  History of hypersensitivity to clotrimazole, clindamycin or lincomycin&#xD;
&#xD;
          -  History of regional enteritis, ulcerative colitis or antibiotic associated colitis&#xD;
&#xD;
          -  Significant disease or acute illness that in the Investigators assessment could&#xD;
             complicate the evaluation&#xD;
&#xD;
          -  Intrauterine Device&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bharti R Daswani, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BJ Govt Medical College &amp; Sassoon General Hospitals, Pune</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BJ Govt. Medical College &amp; Sassoon General Hospitals, Pune</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>October 1, 2012</last_update_submitted>
  <last_update_submitted_qc>October 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Daswani, Bhart, M.D.</investigator_affiliation>
    <investigator_full_name>Dr Bharti Daswani</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Clindamycin</keyword>
  <keyword>Clotrimazole</keyword>
  <keyword>Vaginal formulation</keyword>
  <keyword>Bacterial vaginosis</keyword>
  <keyword>Candidiasis</keyword>
  <keyword>Trichomoniasis</keyword>
  <keyword>Mixed vaginitis</keyword>
  <keyword>Infective vaginitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clindamycin</mesh_term>
    <mesh_term>Clindamycin palmitate</mesh_term>
    <mesh_term>Clindamycin phosphate</mesh_term>
    <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/NCT01697826
org study id: ND1210132-34
secondary id: CTRI/2011/04/001698
nct id: NCT01697826
lead sponsor: 
collaborator: 
has dmc: No
Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and tolerability
      of 2 different vaginal formulations containing 200mg clotrimazole and clindamycin phosphate
      equivalent to 100mg clindamycin for 3 days in women clinically diagnosed to have infective
      vaginitis.
-  This is a Randomized, Comparative, Prospective, Open label, Single center study to
           compare the 3 day treatment course of intravaginal soft gelatin capsule containing
           clindamycin and clotrimazole versus intravaginal ER tablets of clindamycin and
           clotrimazole in patients with vaginal discharge and clinical diagnosis of bacterial,
           trichomonal, candidal or mixed vaginitis with respect to efficacy and tolerability; and
           to study the in vitro drug release pattern of intravaginal soft gelatin capsule and
           intravaginal ER tablets containing clindamycin and clotrimazole.

        -  The study will be conducted in B.J. Medical College & Sassoon General Hospitals, Pune.
           The study will be completed in 60 patients [30 patients in each group].

        -  The primary outcome measure is absence of any clinical sign suggestive of infective
           vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal
           vaginitis at 8th day after start of treatment [Effectiveness in inducing a remission].

        -  The secondary outcome measures will be

             1. absence of any clinical sign suggestive of infective vaginitis and

             2. a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis at
                29th day after start of treatment [Effectiveness in maintaining a remission] and
                ability to complete the 3day course without any break or experiencing intolerable
                side effects [Tolerability].
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary outcome measure for Global effectiveness
time frame: On 8th day after start of treatment
description: Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidal vaginitis
measure: Secondary outcome measures for Global effectiveness
time frame: 29th day after initiation of treatment
description: Number of patients showing absence of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial,trichomonal or candidal vaginitis
measure: Secondary outcome measures for tolerability
time frame: 8th day after start of treatment
description: Number of patients that are able to successfully complete the 3 day treatment course without a break or experiencing intolerable side-effects
measure: Clinical Response
time frame: at 8th day and 29th day after initiation of treatment
description: Number of the patients showing normalization of vaginal pH to 4.5
measure: Clinical response
time frame: at 8th and 29th day after start of treatment
description: Number of the patients achieving improvement in scores for quantity of vaginal discharge by at least 1 unit from baseline
measure: Clinical response
time frame: at 8th day and 29th day after start of treatment
description: Number of the patients achieving improvement in scores for itching by at least 1 unit from baseline
arm group label: ClinSupV3 -soft gelatin capsule
arm group type: Active Comparator
description: Soft gelatin capsule containing 100mg Clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days
arm group label: ClinSupV3ER- Extended release tablet
arm group type: Active Comparator
description: ER tablets containing 100mg clindamycin and 200mg clotrimazole administered per vaginally for 3 consecutive days.
intervention type: Drug
intervention name: ClinSupV3 -soft gelatin capsule
description: 3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole
arm group label: ClinSupV3 -soft gelatin capsule
other name: Clindamycin plus Clotrimazole
intervention type: Drug
intervention name: ClinSupV3ER- Extended release tablet
description: 3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole
arm group label: ClinSupV3ER- Extended release tablet
other name: Clindamycin plus Clotrimazole
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bharti R Daswani, MD, PhD
role: Principal Investigator
affiliation: BJ Govt Medical College & Sassoon General Hospitals, Pune
facility: 
country: India
responsible party type: Sponsor-Investigator
investigator affiliation: Daswani, Bhart, M.D.
investigator full name: Dr Bharti Daswani
investigator title: Dr
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Clindamycin
mesh term: Clindamycin palmitate
mesh term: Clindamycin phosphate
mesh term: Clotrimazole
mesh term: Miconazole