<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/NCT01690221</url>
  </required_header>
  <id_info>
    <org_study_id>VEN307-AF-001</org_study_id>
    <nct_id>NCT01690221</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study With Diltiazem Hydrochloride Cream to Treat Anal Fissures</brief_title>
  <official_title>A Phase 3B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Topical Diltiazem Hydrochloride 2% Cream in Subjects With Anal Fissure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ventrus Biosciences, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ventrus Biosciences, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the study drug, VEN307 (diltiazem hydrochloride&#xD;
      cream) is safe and to see if it will help with treatment of pain associated with anal&#xD;
      fissures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To evaluate the efficacy of diltiazem hydrochloride cream on reduction of worst anal fissure&#xD;
      (AF)-related pain associated with or following defecation when administered three times a day&#xD;
      (TID) for 28 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Change from baseline (average NRS during the last 3 days in which subject had a defecation during the 7 day screening period) in average of worst AF-related pain associated with or following defecation for Days 22-28 (Week 4).</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">434</enrollment>
  <condition>Chronic Anal Fissures</condition>
  <arm_group>
    <arm_group_label>VEN 307</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>diltiazem hydrochloride 2% cream</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Cream</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VEN 307</intervention_name>
    <description>VEN307 applied three times a day, in and around the anus, for 28 days.</description>
    <arm_group_label>VEN 307</arm_group_label>
    <other_name>diltiazem hydrochloride 2% cream</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo cream applied three times a day, in and around the anus, for 28 days.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo cream</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females, aged ≥ 18 to ≤ 75 years.&#xD;
&#xD;
          2. Subjects with evidence of a circumscribed fissure, with induration at the edges.&#xD;
&#xD;
          3. Subjects with AF-related pain associated with or following defecation occurring at&#xD;
             least 2 times a week for at least 28 days prior to signing the informed consent form&#xD;
             (ICF).&#xD;
&#xD;
          4. AF-related pain associated with or following defecation of at least 5 on an 11-point&#xD;
             numerical rating score scale (NRS) at the last defecation prior to signing the ICF (0&#xD;
             being no pain; 10 being the worst possible pain).&#xD;
&#xD;
          5. Average AF-related pain associated with or following defecation of at least 5 on an&#xD;
             11-point NRS during the last 3 days in which subject had a defecation during the 7&#xD;
             days prior to randomization.&#xD;
&#xD;
          6. Any female of non-childbearing potential, including any female who: a) has had a&#xD;
             hysterectomy, b) has had a bilateral oophorectomy, c) has had a bilateral tubal&#xD;
             ligation or d) is post menopausal (demonstration of total cessation of menses for ≥ 1&#xD;
             year from the date of screening visit).&#xD;
&#xD;
          7. Females of child bearing potential who agree to use at least one form of contraception&#xD;
             (may be a barrier method), during the full duration of the study.&#xD;
&#xD;
          8. Able to communicate adequately with the investigator and to comply with the&#xD;
             requirements for the entire study.&#xD;
&#xD;
          9. Capable of using the IVRS and able to adequately communicate comprehension of the IVRS&#xD;
             questions to the investigator.&#xD;
&#xD;
         10. Capable of and freely willing to provide written informed consent prior to&#xD;
             participating in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwilling to have visual or medical examination of the AF.&#xD;
&#xD;
          2. More than 1 AF.&#xD;
&#xD;
          3. Subjects with AF associated with or caused by other conditions, including but not&#xD;
             limited to: drug-induced, trauma, HIV infection, fistula-in-ano, inflammatory bowel&#xD;
             disease, perianal sepsis or malignancy.&#xD;
&#xD;
          4. Unwilling to stop all other concomitant topical preparations applied in and around the&#xD;
             anus from signing of ICF through Day 29 of the study.&#xD;
&#xD;
          5. Use of glyceryl trinitrate (GTN) ointment for 7 days (continuous or not) in the 28&#xD;
             days prior to signing the ICF.&#xD;
&#xD;
          6. Unwilling to discontinue use of sitz baths for up to 4 hours after each application of&#xD;
             investigational product from signing of ICF to end of study.&#xD;
&#xD;
          7. Unwilling to discontinue use of anesthetics from signing the ICF to end of study.&#xD;
&#xD;
          8. Subfissure injection of botulinum toxin in the 3 months prior to signing the ICF.&#xD;
&#xD;
          9. Known sensitivity to investigational product(s) or calcium channel blockers.&#xD;
&#xD;
         10. Previous treatment with diltiazem hydrochloride cream or any other topical calcium&#xD;
             channel blockers.&#xD;
&#xD;
         11. Active treatment with anti-viral therapies for HIV (e.g. indinavir, nelfinivir,&#xD;
             ritonavir).&#xD;
&#xD;
         12. Treatment with any of the following medications within 14 days prior to signing the&#xD;
             ICF:&#xD;
&#xD;
               -  Amitriptyline&#xD;
&#xD;
               -  Benzodiazepines&#xD;
&#xD;
               -  β-adrenoceptor antagonists (Beta-Blockers)&#xD;
&#xD;
               -  Buspirone&#xD;
&#xD;
               -  Calcium channel blockers&#xD;
&#xD;
               -  Carbamazepine&#xD;
&#xD;
               -  Cimetidine&#xD;
&#xD;
               -  Cyclosporin&#xD;
&#xD;
               -  Digoxin&#xD;
&#xD;
               -  Investigational agents&#xD;
&#xD;
               -  Lovastatin&#xD;
&#xD;
               -  Opioids&#xD;
&#xD;
               -  Pregabalin&#xD;
&#xD;
               -  Quinidine&#xD;
&#xD;
               -  Rifampin&#xD;
&#xD;
         13. Following concomitant disease state:&#xD;
&#xD;
               -  Sick sinus syndrome except in the presence of a functioning ventricular&#xD;
                  pacemaker.&#xD;
&#xD;
               -  Second-or third-degree AV block except in the presence of a functioning&#xD;
                  ventricular pacemaker.&#xD;
&#xD;
               -  Hypotension (less than 90 mm Hg systolic).&#xD;
&#xD;
               -  Acute myocardial infarction and pulmonary congestion documented by x-ray.&#xD;
&#xD;
               -  History of bipolar disorder, psychosis, schizophrenia, mania, suicide attempt or&#xD;
                  suicidal ideation, or any other significant psychiatric illness (with the&#xD;
                  exception of intermittent anxiety) per investigator judgment.&#xD;
&#xD;
               -  History of clinically significant renal disease per investigator judgment.&#xD;
&#xD;
               -  History of clinically significant Alzheimer's or Parkinson's disease per&#xD;
                  investigator judgment.&#xD;
&#xD;
               -  History of clinically significant hepatic disease per investigator judgment.&#xD;
&#xD;
               -  Current infection treated with a macrolide antibiotic.&#xD;
&#xD;
               -  Clinical evidence or history of fecal incontinence.&#xD;
&#xD;
               -  Clinical evidence or history of anal fistula.&#xD;
&#xD;
               -  Clinical evidence or history of anal abscess.&#xD;
&#xD;
               -  History of inflammatory bowel disease (e.g. Crohn's disease, Ulcerative Colitis).&#xD;
&#xD;
               -  History of any prior anal or rectal surgery including but not limited to: lateral&#xD;
                  sphincterotomy and anal stretch (with the exception of hemorrhoidal banding and&#xD;
                  laser surgery).&#xD;
&#xD;
               -  Grade 4 hemorrhoids.&#xD;
&#xD;
               -  Chronic constipation.&#xD;
&#xD;
         14. History of radiation therapy to the pelvis.&#xD;
&#xD;
         15. Fixed anal stenosis/fibrosis.&#xD;
&#xD;
         16. Major organ transplant.&#xD;
&#xD;
         17. Any clinically significant laboratory abnormalities during screening per investigator&#xD;
             judgment.&#xD;
&#xD;
         18. Body Mass Index (BMI) &gt; 40 kg/m2&#xD;
&#xD;
         19. Malignancy within 5 years prior to randomization (with the exception of treated basal&#xD;
             cell/squamous cell carcinoma of the skin).&#xD;
&#xD;
         20. Any disease or prior/planned surgery that may interfere with the subject successfully&#xD;
             completing the study.&#xD;
&#xD;
         21. Currently using narcotic(s).&#xD;
&#xD;
         22. Breast-feeding females.&#xD;
&#xD;
         23. Employees, family members, or students of the investigator or clinical site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Crawford Clinic</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Surgical Association of Mobile</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Alabama</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montgomery Women's Health Association, PC</name>
      <address>
        <city>Montgomery</city>
        <state>Alabama</state>
        <zip>36117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Sun Clinical Research, LLC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arrowhead Regional Medical Center</name>
      <address>
        <city>Colton</city>
        <state>California</state>
        <zip>92324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Research Centers</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axis Clinical Trials</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastrointestinal Biosciences</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California - Irvine Medical Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Care Associated, A Medical Corporation</name>
      <address>
        <city>San Carlos</city>
        <state>California</state>
        <zip>94070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Coast Clinical Research</name>
      <address>
        <city>Tarzana</city>
        <state>California</state>
        <zip>91356</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Clinical Research, LLC</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Research Works</name>
      <address>
        <city>Pueblo</city>
        <state>Colorado</state>
        <zip>81008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Clinical Research, LLC</name>
      <address>
        <city>Thornton</city>
        <state>Colorado</state>
        <zip>80229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connecticut Clinical Research Foundation CT Gastroenterology Institute At Bristol Hospital</name>
      <address>
        <city>Bristol</city>
        <state>Connecticut</state>
        <zip>06010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital Center - MedStar Health Research Institute</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Medical Research of South Florida</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Lake Pain Institute</name>
      <address>
        <city>Clermont</city>
        <state>Florida</state>
        <zip>34711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akta Medika</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advance Medical Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Well Pharma Medical Research Corp.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Group of Naples, PA</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthcare Clinical Data, Inc.</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Medical Research Center</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida, South Campus</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Medical Clinic, P.A.</name>
      <address>
        <city>Zephyrhills</city>
        <state>Florida</state>
        <zip>33542</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morehouse School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Health Sciences University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Center for Gastroenterology</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastrointestinal Specialist of Georgia</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Gastroenterology Consultants</name>
      <address>
        <city>Suwanee</city>
        <state>Georgia</state>
        <zip>30024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NCH Medical Group</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore University Health System</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University School of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kendrick Regional Medical Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospital and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202-1622</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delta Research Partners</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Clinical Research</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metropolitan Gastroenterology Group, Chevy Chase Clinical Research</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro Center of Maryland</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meritus Center For Clinical Research</name>
      <address>
        <city>Hagerstown</city>
        <state>Maryland</state>
        <zip>21742</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Center Department of Surgery</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Digestive Health</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRC of Jackson</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jefferson City Medical Group</name>
      <address>
        <city>Jefferson City</city>
        <state>Missouri</state>
        <zip>65109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Center for Clinical Research</name>
      <address>
        <city>Lee's Summit</city>
        <state>Missouri</state>
        <zip>64064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colon and Rectal Surgery, Inc</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Impact Clinical Trials</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Group &amp; Endoscopy Center of South NJ (GGSJ)</name>
      <address>
        <city>Vineland</city>
        <state>New Jersey</state>
        <zip>08360-7072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C&amp;R Surgical Assoc of South Jersey</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043-9544</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Life Medi-Research and Management</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCCA Clinical Research Solutions</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhattan Surgical Associates, LLP</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorectal Associates of NY</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research Associates of New York (New York Gastroenterology Associates, LLP)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Medical Group</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medispect</name>
      <address>
        <city>Boone</city>
        <state>North Carolina</state>
        <zip>28607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Womack Army Medical Center</name>
      <address>
        <city>Ft. Bragg</city>
        <state>North Carolina</state>
        <zip>28310-7301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trial Management Associates</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Gastroenterology, Inc.</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Gastroenterology</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Pain Research</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bend Memorial Clinic</name>
      <address>
        <city>Bend</city>
        <state>Oregon</state>
        <zip>97701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Corvallis Clinic, Clinical Research Center</name>
      <address>
        <city>Corvallis</city>
        <state>Oregon</state>
        <zip>97330</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westover Heights Clinic</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Penn Allegheny Health System</name>
      <address>
        <city>Monroeville</city>
        <state>Pennsylvania</state>
        <zip>15146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drexel Univ College of Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Physicians, Jeanes Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pain Specialists of Charleston</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Orangeburg, PA</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCCA Clinical Research Solutions</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Univ Dept of Colon and Rectal Surgery</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Across America</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Concepts, GP LLC</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of TX Affiliated Hospitals</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Endoscopy and Research Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Digestive Disease Clinic</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090-3408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ColoProctology Associates</name>
      <address>
        <city>Seabrook</city>
        <state>Texas</state>
        <zip>77586</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah HSC</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlottesville Medical Research</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Tidewater</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jefferson Surgical Clinic</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NW Gastroenterology</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Disease Institute, Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Madigan Army Medical Center</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin Department of Surgery</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>January 22, 2014</last_update_submitted>
  <last_update_submitted_qc>January 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anal</keyword>
  <keyword>Fissure</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fissure in Ano</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diltiazem</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>March 6, 2014</submitted>
    <returned>April 15, 2014</returned>
  </pending_results>
  <!-- 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/NCT01690221
org study id: VEN307-AF-001
nct id: NCT01690221
lead sponsor: 
has dmc: No
The purpose of this study is to determine if the study drug, VEN307 (diltiazem hydrochloride
      cream) is safe and to see if it will help with treatment of pain associated with anal
      fissures.
Primary Objective:

      To evaluate the efficacy of diltiazem hydrochloride cream on reduction of worst anal fissure
      (AF)-related pain associated with or following defecation when administered three times a day
      (TID) for 28 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline (average NRS during the last 3 days in which subject had a defecation during the 7 day screening period) in average of worst AF-related pain associated with or following defecation for Days 22-28 (Week 4).
time frame: 28 days
arm group label: VEN 307
arm group type: Experimental
description: diltiazem hydrochloride 2% cream
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Cream
intervention type: Drug
intervention name: VEN 307
description: VEN307 applied three times a day, in and around the anus, for 28 days.
arm group label: VEN 307
other name: diltiazem hydrochloride 2% cream
intervention type: Drug
intervention name: Placebo
description: Placebo cream applied three times a day, in and around the anus, for 28 days.
arm group label: Placebo
other name: Placebo cream
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Fissure in Ano
mesh term: Diltiazem
submitted: March 6, 2014
returned: April 15, 2014