<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/NCT03757403</url>
  </required_header>
  <id_info>
    <org_study_id>RDD123</org_study_id>
    <nct_id>NCT03757403</nct_id>
  </id_info>
  <brief_title>RDD1609 as a Treatment for Idiopathic Pruritus Ani</brief_title>
  <official_title>RDD1609 as a Treatment for Idiopathic Pruritus Ani: A Randomized Double Blinded Placebo Controlled Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RDD Pharma Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RDD Pharma Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a double-blind, randomized, placebo-controlled, crossover trial, to test the&#xD;
      hypothesis that RDD1609 is effective in treating idiopathic pruritus ani.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase 2a randomized double-blinded placebo-controlled cross-over design study in&#xD;
      patients with idiopathic pruritus ani. 24 patients, male and females, aged 18 -65 with severe&#xD;
      idiopathic pruritus ani (VAS score above 60), will be randomized to this study.&#xD;
&#xD;
      Patients that meet all inclusion criteria and do not have exclusion criteria at randomization&#xD;
      visit will be randomly assigned to one of the two treatment groups:&#xD;
&#xD;
      Group 1 will receive 3 weeks of RDD1609 for 3 weeks, followed by 3 weeks of treatment with&#xD;
      placebo.&#xD;
&#xD;
      Group 2 will receive 3 weeks of treatment with placebo followed by 3 weeks of treatment with&#xD;
      RDD1609.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Covid-19&#xD;
  </why_stopped>
  <start_date type="Anticipated">May 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>phase 2a randomized double-blinded placebo-controlled cross-over</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale (VAS) for itching</measure>
    <time_frame>3 weeks</time_frame>
    <description>Change in severity of itch, measured using Visual Analogue Scale score for itching from baseline through the end of treatment. The Visual Analogue Scale is a 10-cm long line (oriented horizontally), on which patients indicate the severity of their itching by crossing the line at the point that corresponded to their itching severity. The left end of the line indicates &quot;no itch&quot; and right end of the line indicates &quot;worth itch ever&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pruritus Ani Severity Index score</measure>
    <time_frame>3 weeks</time_frame>
    <description>Effect of RDD1609 on the Pruritus Ani Severity Index score (Mild, Moderate, Severe, Chronic), which is a grading system used to describe severity of physical findings in patients with pruritus ani.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability of RDD1609 ( the frequency of adverse events and serious adverse events)</measure>
    <time_frame>3 weeks</time_frame>
    <description>Will be based primarily on the frequency of adverse events and serious adverse events. Other safety data will be summarized as appropriate.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Dermatology Life Quality Index</measure>
    <time_frame>3 weeks</time_frame>
    <description>Effect of treatment on Dermatology Life Quality Index.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Idiopathic Pruritus Ani</condition>
  <arm_group>
    <arm_group_label>RDD1609 followed by Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application on the perianal area BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo followed by RDD1609</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application on the perianal area BID</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RDD1609</intervention_name>
    <description>RDD1609 to be applied on the perianal area BID</description>
    <arm_group_label>Placebo followed by RDD1609</arm_group_label>
    <arm_group_label>RDD1609 followed by Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mebendazole 100 MG</intervention_name>
    <description>Mebendazole 100 mg single dose (single prophylactic dose of the anthelmintic medicine)</description>
    <arm_group_label>Placebo followed by RDD1609</arm_group_label>
    <arm_group_label>RDD1609 followed by Placebo</arm_group_label>
    <other_name>Vermox</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. An Institutional Review Board (IRB) approved informed consent is signed and dated&#xD;
             prior to any study-related activities.&#xD;
&#xD;
          2. Male and female patients, age 18 - 65 years with idiopathic PA.&#xD;
&#xD;
          3. Screening VAS for itching of 60 mm and above.&#xD;
&#xD;
          4. Female subjects of child-bearing potential must have a negative urine pregnancy test.&#xD;
             Females of childbearing potential must practice a highly effective method of pregnancy&#xD;
             prevention (defined as &lt;1% pregnancies per 100 women per year) from one month before&#xD;
             screening to one month after the follow-up visit, such as: surgical sterilization,&#xD;
             hormonal implant, intrauterine device, or male condom + female diaphragm + vaginal&#xD;
             spermicide. Female subject with any of the following circumstances is not required to&#xD;
             use a highly effective method of pregnancy prevention: status post-hysterectomy; or,&#xD;
             status post-tubal ligation; or, post-menopausal state (defined as &gt;= 12 months of&#xD;
             spontaneous amenorrhea) or &lt; 12 months of spontaneous amenorrhea with a blood follicle&#xD;
             stimulating hormone &gt; 40 MIU/ml.&#xD;
&#xD;
          5. Subject has normal (or abnormal and clinically insignificant) laboratory values at&#xD;
             Screening.&#xD;
&#xD;
          6. Subject has the ability to understand the requirements of the study and a willingness&#xD;
             to comply with all study procedures.&#xD;
&#xD;
          7. Subject has not used and agrees to abstain from taking any prescription or&#xD;
             non-prescription medications, cosmetics, including herbal and dietary supplements&#xD;
             (such as St. John's wort) within 7 days prior to the first dose of study medication&#xD;
             (unless authorized by the Investigator and Medical Monitor).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known hypersensitivity to RDD1609.&#xD;
&#xD;
          2. Known hypersensitivity to Mebendazole.&#xD;
&#xD;
          3. Previously treated with methylene blue for pruritus ani.&#xD;
&#xD;
          4. Randomization VAS for itching that is &lt;25 mm than the screening VAS.&#xD;
&#xD;
          5. Anorectal conditions such as malignant tumors of the anus and rectum, inflammatory&#xD;
             bowel disease, fistulain- ano, fissure-in-ano, incontinence, condylomata, and second-&#xD;
             and third-degree hemorrhoids and any other anorectal conditions that requires&#xD;
             medicinal treatment.&#xD;
&#xD;
          6. Patients who had previous major proctological surgery.&#xD;
&#xD;
          7. Generalized skin disorders.&#xD;
&#xD;
          8. Active psychiatric disorders.&#xD;
&#xD;
          9. Diabetes mellitus all types.&#xD;
&#xD;
         10. Known to be HIV positive.&#xD;
&#xD;
         11. Current or within the last 4 weeks steroid or pregabalin or gabapentin or&#xD;
             antihistamine systemic or local treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nir Barak, MD</last_name>
    <role>Study Chair</role>
    <affiliation>RDD Pharma Ltd</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeanette Melrose, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>THE ATHERSTONE SURGERY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Atherstone Surgery</name>
      <address>
        <city>Atherstone</city>
        <zip>CV9 1EU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Bristol NHS Foundation Trust- Location Bristol Royal Infirmary</name>
      <address>
        <city>Bristol</city>
        <zip>IG95LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings Medical Centre</name>
      <address>
        <city>Buckhurst Hill</city>
        <zip>IG95LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheepcot Medical Centre</name>
      <address>
        <city>Watford</city>
        <zip>WD25 7NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2022</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>Pruritus Ani</mesh_term>
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mebendazole</mesh_term>
    <mesh_term>Piperazine</mesh_term>
    <mesh_term>Piperazine citrate</mesh_term>
    <mesh_term>DMP 777</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/NCT03757403
org study id: RDD123
nct id: NCT03757403
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a double-blind, randomized, placebo-controlled, crossover trial, to test the
      hypothesis that RDD1609 is effective in treating idiopathic pruritus ani.
This is a phase 2a randomized double-blinded placebo-controlled cross-over design study in
      patients with idiopathic pruritus ani. 24 patients, male and females, aged 18 -65 with severe
      idiopathic pruritus ani (VAS score above 60), will be randomized to this study.

      Patients that meet all inclusion criteria and do not have exclusion criteria at randomization
      visit will be randomly assigned to one of the two treatment groups:

      Group 1 will receive 3 weeks of RDD1609 for 3 weeks, followed by 3 weeks of treatment with
      placebo.

      Group 2 will receive 3 weeks of treatment with placebo followed by 3 weeks of treatment with
      RDD1609.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: phase 2a randomized double-blinded placebo-controlled cross-over
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Visual Analogue Scale (VAS) for itching
time frame: 3 weeks
description: Change in severity of itch, measured using Visual Analogue Scale score for itching from baseline through the end of treatment. The Visual Analogue Scale is a 10-cm long line (oriented horizontally), on which patients indicate the severity of their itching by crossing the line at the point that corresponded to their itching severity. The left end of the line indicates "no itch" and right end of the line indicates "worth itch ever".
measure: Pruritus Ani Severity Index score
time frame: 3 weeks
description: Effect of RDD1609 on the Pruritus Ani Severity Index score (Mild, Moderate, Severe, Chronic), which is a grading system used to describe severity of physical findings in patients with pruritus ani.
measure: Safety and Tolerability of RDD1609 ( the frequency of adverse events and serious adverse events)
time frame: 3 weeks
description: Will be based primarily on the frequency of adverse events and serious adverse events. Other safety data will be summarized as appropriate.
measure: Dermatology Life Quality Index
time frame: 3 weeks
description: Effect of treatment on Dermatology Life Quality Index.
arm group label: RDD1609 followed by Placebo
arm group type: Experimental
description: Application on the perianal area BID
arm group label: Placebo followed by RDD1609
arm group type: Experimental
description: Application on the perianal area BID
intervention type: Drug
intervention name: RDD1609
description: RDD1609 to be applied on the perianal area BID
arm group label: Placebo followed by RDD1609
arm group label: RDD1609 followed by Placebo
intervention type: Drug
intervention name: Mebendazole 100 MG
description: Mebendazole 100 mg single dose (single prophylactic dose of the anthelmintic medicine)
arm group label: Placebo followed by RDD1609
arm group label: RDD1609 followed by Placebo
other name: Vermox
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Nir Barak, MD
role: Study Chair
affiliation: RDD Pharma Ltd
last name: Jeanette Melrose, MD
role: Principal Investigator
affiliation: THE ATHERSTONE SURGERY
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Pruritus Ani
mesh term: Pruritus
mesh term: Mebendazole
mesh term: Piperazine
mesh term: Piperazine citrate
mesh term: DMP 777