<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/NCT01733966</url>
  </required_header>
  <id_info>
    <org_study_id>IPR_SIGMO_09</org_study_id>
    <nct_id>NCT01733966</nct_id>
    <nct_alias>NCT01136434</nct_alias>
  </id_info>
  <brief_title>A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults</brief_title>
  <acronym>DIVA</acronym>
  <official_title>A Third Phase, Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Quanta Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratoires Iprad-Vegebom</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Quanta Medical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary outcome measure is to compare efficacy of an association of&#xD;
      Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid&#xD;
      during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among&#xD;
      Adults in clinical and biological cure.&#xD;
&#xD;
      The cure rate will be evaluated at the second visit (14 days after the inclusion visit)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    difficulties to recruit patients who suffer from this pathology&#xD;
  </why_stopped>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>comparaison of the efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for clinical and biological cure</measure>
    <time_frame>the cure rate will be evaluated at the second visit (14 days after the inclusion visit)</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Diverticular Sigmoïditis</condition>
  <arm_group>
    <arm_group_label>Secnidazol-Ciprofloxacin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amoxicillin-Clavulanic Acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Secnidazole, ciprofloxacine</intervention_name>
    <description>2g of microgranules of secnidazole. a single dose per day during 3 days.&#xD;
1g of Ciprofloxacin (2 tablets of 500mg per day during 3 days)</description>
    <arm_group_label>Secnidazol-Ciprofloxacin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin-Clavulanic Acid</intervention_name>
    <description>3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days)</description>
    <arm_group_label>Amoxicillin-Clavulanic Acid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult&#xD;
&#xD;
          -  Recovering of written and dated informed consent form&#xD;
&#xD;
          -  Social Security medical cover&#xD;
&#xD;
          -  Left Iliac Fossa (LIF) pain&#xD;
&#xD;
          -  Moderate fever (&gt;37.8°C)&#xD;
&#xD;
          -  Sensitivity/defence during LIF palpation&#xD;
&#xD;
        Biological results :&#xD;
&#xD;
          -  CRP &gt; 10mg/L&#xD;
&#xD;
          -  NFS &gt; 10G/L&#xD;
&#xD;
          -  Neutrophil Granulocytosis &gt; 75%&#xD;
&#xD;
          -  Radiological results - presence to the scan :diverticul &amp; pericolic infiltration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients treated by antibiotherapy in the last 15 days prior inclusion&#xD;
&#xD;
          -  Patients treated by morphinic drug&#xD;
&#xD;
          -  Patients treated by anticoagulant drug&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Patients presenting allergy to active principal, to galactose&#xD;
&#xD;
          -  Patients having taking part in another study in the last 3 months prior inclusion&#xD;
&#xD;
          -  Patients unable to comply with the study requirements&#xD;
&#xD;
          -  Patients presenting Chronic affection inconsistent with the study&#xD;
&#xD;
          -  Patients presenting high fever&#xD;
&#xD;
          -  Patients presenting abdominal contracture&#xD;
&#xD;
          -  Patients presenting immunosuppression&#xD;
&#xD;
          -  Radiological sign of complication (abscess&gt;3cm)&#xD;
&#xD;
          -  Patients presenting Pathology inconsistent with efficacy evaluatio&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2010</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>September 13, 2018</last_update_submitted>
  <last_update_submitted_qc>September 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2018</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>Colitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Clavulanic Acids</mesh_term>
    <mesh_term>Clavulanic Acid</mesh_term>
    <mesh_term>Amoxicillin-Potassium Clavulanate Combination</mesh_term>
    <mesh_term>Ciprofloxacin</mesh_term>
    <mesh_term>Secnidazole</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/NCT01733966
org study id: IPR_SIGMO_09
nct id: NCT01733966
nct alias: NCT01136434
lead sponsor: 
collaborator: 
has dmc: Yes
The primary outcome measure is to compare efficacy of an association of
      Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid
      during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among
      Adults in clinical and biological cure.

      The cure rate will be evaluated at the second visit (14 days after the inclusion visit)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: comparaison of the efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for clinical and biological cure
time frame: the cure rate will be evaluated at the second visit (14 days after the inclusion visit)
arm group label: Secnidazol-Ciprofloxacin
arm group type: Experimental
description: 2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 days
arm group label: Amoxicillin-Clavulanic Acid
arm group type: Active Comparator
description: 3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days
intervention type: Drug
intervention name: Secnidazole, ciprofloxacine
description: 2g of microgranules of secnidazole. a single dose per day during 3 days.
1g of Ciprofloxacin (2 tablets of 500mg per day during 3 days)
arm group label: Secnidazol-Ciprofloxacin
intervention type: Drug
intervention name: Amoxicillin-Clavulanic Acid
description: 3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days)
arm group label: Amoxicillin-Clavulanic Acid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Colitis
mesh term: Amoxicillin
mesh term: Clavulanic Acids
mesh term: Clavulanic Acid
mesh term: Amoxicillin-Potassium Clavulanate Combination
mesh term: Ciprofloxacin
mesh term: Secnidazole