<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/NCT03833076</url>
  </required_header>
  <id_info>
    <org_study_id>ProctoMD01</org_study_id>
    <nct_id>NCT03833076</nct_id>
  </id_info>
  <brief_title>A New Class IIb MD in Proctological Disorders</brief_title>
  <official_title>Evaluation of Performance and Safety of a New Medical Device Class IIb Not Yet CE Marked in Proctological Disorders: a Randomised, Double-blind, Parallel-groups, Multicentric, Placebo-controlled, Prospective Clinical Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nathura S.p.A</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Evidilya S.r.l.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nathura S.p.A</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>
      The aim of this study is primarily to investigate the performance of a new medical device not&#xD;
      yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult&#xD;
      patients reporting symptoms of hemorrhoids (grade 1-3), anal fissures and proctitides.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2019</start_date>
  <completion_date type="Actual">November 27, 2020</completion_date>
  <primary_completion_date type="Actual">November 27, 2020</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>a randomised, double-blind, parallel-groups, multicentric, placebo-controlled, prospective clinical study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of symptoms according to the Proctological Symptom Scale (PSS)</measure>
    <time_frame>from Day 0 to Day 14</time_frame>
    <description>Assessment of symptoms according to the Proctological Symptom Scale - PSS (according to 100 mm Visual Analogue Scales; from &quot;no symptoms&quot; to &quot;overwhelming symptoms); comparison between groups, from Day 0 to Day 14</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator's assessment of signs</measure>
    <time_frame>from Day 0 to Day 14</time_frame>
    <description>Investigator's assessment of signs: anal pain, inflammation and visible bleeding, categorized as none, mild, moderate, or severe (corresponding to a score of 0, 1, 2 or 3, respectively); comparison between groups, from Day 0 to Day 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessments done by Investigator of overall improvement</measure>
    <time_frame>from Day 0 to Day 14</time_frame>
    <description>Assessments done by Investigator of overall improvement by means of Global Assessment of Improvement (GAI - according to a 7-grade scoring system, 0-6); comparison between groups, at Day 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-assessment of subjective symptoms</measure>
    <time_frame>from Day 0 to Day 14</time_frame>
    <description>Self-assessment of subjective symptoms (anal pain, pain or discomfort during evacuation, itching, irritation or inflammation, bleeding) by means of 100 mm Visual Analogue Scales (from &quot;no symptoms&quot; to &quot;overwhelming symptoms&quot;); comparison between groups, from Day 0 to Day 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-assessment of overall treatment</measure>
    <time_frame>from Day 0 to Day 14</time_frame>
    <description>Self-assessment of overall treatment by means of Overall Treatment Evaluation (OTE - according to a 15-point scale; from -7 to -1 = worse; 0 = no change; from +1 to +7 = better); comparison between groups, at Day 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient willingness</measure>
    <time_frame>from Day 0 to Day 14</time_frame>
    <description>Patient willingness to use the product in the future, assessed on 1 - 4 points scale (strongly disagree=1, disagree=2, agree=3, strongly agree=4); comparison between groups, at Day 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of rescue product</measure>
    <time_frame>from Day 0 to Day 14</time_frame>
    <description>Assessment of rescue product use (starting date the rescue product was used); comparison among groups, at Day 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of rescue product</measure>
    <time_frame>from Day 0 to Day 14</time_frame>
    <description>Assessment of rescue product use (number of times the rescue product was used); comparison among groups, at Day 14.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Proctological Disorders</condition>
  <arm_group>
    <arm_group_label>GROUP A: Medical Device Procto</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medical device Procto presents itself as a translucent green gel with a typical smell; it is intended for topical use.&#xD;
Posology: external or internal use by means of the provided rectal applicator and following the instructions on the package insert. It can be applied when needed, after intimate cleansing, at any time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GROUP B: Matching placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Investigational Product (IP) placebo presents itself as a translucent green gel with a typical smell; it is intended for topical use.&#xD;
Posology: external or internal use by means of the provided rectal applicator and following the instructions on the package insert. It can be applied when needed, after intimate cleansing, at any time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medical device Procto</intervention_name>
    <description>Medical device Procto presents itself as a translucent green gel with a typical smell.</description>
    <arm_group_label>GROUP A: Medical Device Procto</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Matching placebo</intervention_name>
    <description>IP placebo presents itself as a translucent green gel with a typical smell.</description>
    <arm_group_label>GROUP B: Matching placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients of both sexes aged between 18 and 75 years.&#xD;
&#xD;
          2. Patients reporting symptoms of haemorrhoids (grade 1-3*), anal fissures and&#xD;
             proctitides or already diagnosed with haemorrhoids (grade 1-3), anal fissures and&#xD;
             proctitides; diagnosis confirmed by proctological examination at Screening Visit.&#xD;
&#xD;
             *Grade 1 - Haemorrhoid protrudes into the anal canal but does not prolapse outside the&#xD;
             anus.&#xD;
&#xD;
             Grade 2 - Haemorrhoid protrudes through the anus during straining or evacuation but&#xD;
             returns spontaneously.&#xD;
&#xD;
             Grade 3 - Haemorrhoid protrudes through the anus during straining or evacuation but&#xD;
             needs to be manually returned to position.&#xD;
&#xD;
             Grade 4 - Haemorrhoid remains prolapsed outside of the anus.&#xD;
&#xD;
          3. Patients agreeing not to use any other systemic or topic medicinal / product to treat&#xD;
             haemorrhoids, anal fissures and proctitides during the study and not to modify their&#xD;
             personal hygiene products.&#xD;
&#xD;
          4. Female patients of childbearing potential following a reliable contraceptive method&#xD;
             (according to Investigator's opinion).&#xD;
&#xD;
          5. Willingness to participate in the study and to sign an informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients presenting infective anal or rectal pathologies (in particular bacterial&#xD;
             infections associated with proctitides or proctitides caused by viral infections).&#xD;
&#xD;
          2. Patients presenting complicated haemorrhoids.&#xD;
&#xD;
          3. Patients with Crohn's disease or malignancy.&#xD;
&#xD;
          4. Patients presenting undiagnosed abnormal rectal bleeding.&#xD;
&#xD;
          5. Patients with known or suspected rectal hypersensitivity.&#xD;
&#xD;
          6. Patients presenting coagulation disorders or on anticoagulant drug therapy (except&#xD;
             clopidogrel or acetylsalicylic acid).&#xD;
&#xD;
          7. Patients in treatment with topic or systemic medications / products to treat&#xD;
             haemorrhoids, fissures and proctitides, currently or in the 2 weeks prior to Screening&#xD;
             Visit.&#xD;
&#xD;
          8. Patients using laxatives or stool softener currently or in the 2 weeks prior to&#xD;
             Screening Visit.&#xD;
&#xD;
          9. Patients pregnant or breastfeeding.&#xD;
&#xD;
         10. Patients reporting past or present narcotic addiction or alcoholism.&#xD;
&#xD;
         11. Patients that participated in any other clinical trial during the last month or&#xD;
             participating in any clinical trial while participating in this trial.&#xD;
&#xD;
         12. Patients reporting allergy or intolerance to any component of test product, placebo or&#xD;
             rescue product.&#xD;
&#xD;
         13. Patients who in the opinion of the principal Investigator are at risk of&#xD;
             non-compliance to the study procedures or who are otherwise not appropriate to include&#xD;
             in this clinical trial.&#xD;
&#xD;
         14. Patients presenting contraindications to Proktis-M (rescue product), according to&#xD;
             concerning leaflet.&#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>Isituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>December 22, 2020</last_update_submitted>
  <last_update_submitted_qc>December 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03833076
org study id: ProctoMD01
nct id: NCT03833076
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is primarily to investigate the performance of a new medical device not
      yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult
      patients reporting symptoms of hemorrhoids (grade 1-3), anal fissures and proctitides.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: a randomised, double-blind, parallel-groups, multicentric, placebo-controlled, prospective clinical study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Assessment of symptoms according to the Proctological Symptom Scale (PSS)
time frame: from Day 0 to Day 14
description: Assessment of symptoms according to the Proctological Symptom Scale - PSS (according to 100 mm Visual Analogue Scales; from "no symptoms" to "overwhelming symptoms); comparison between groups, from Day 0 to Day 14
measure: Investigator's assessment of signs
time frame: from Day 0 to Day 14
description: Investigator's assessment of signs: anal pain, inflammation and visible bleeding, categorized as none, mild, moderate, or severe (corresponding to a score of 0, 1, 2 or 3, respectively); comparison between groups, from Day 0 to Day 14.
measure: Assessments done by Investigator of overall improvement
time frame: from Day 0 to Day 14
description: Assessments done by Investigator of overall improvement by means of Global Assessment of Improvement (GAI - according to a 7-grade scoring system, 0-6); comparison between groups, at Day 14.
measure: Self-assessment of subjective symptoms
time frame: from Day 0 to Day 14
description: Self-assessment of subjective symptoms (anal pain, pain or discomfort during evacuation, itching, irritation or inflammation, bleeding) by means of 100 mm Visual Analogue Scales (from "no symptoms" to "overwhelming symptoms"); comparison between groups, from Day 0 to Day 14.
measure: Self-assessment of overall treatment
time frame: from Day 0 to Day 14
description: Self-assessment of overall treatment by means of Overall Treatment Evaluation (OTE - according to a 15-point scale; from -7 to -1 = worse; 0 = no change; from +1 to +7 = better); comparison between groups, at Day 14.
measure: Patient willingness
time frame: from Day 0 to Day 14
description: Patient willingness to use the product in the future, assessed on 1 - 4 points scale (strongly disagree=1, disagree=2, agree=3, strongly agree=4); comparison between groups, at Day 14.
measure: Assessment of rescue product
time frame: from Day 0 to Day 14
description: Assessment of rescue product use (starting date the rescue product was used); comparison among groups, at Day 14.
measure: Assessment of rescue product
time frame: from Day 0 to Day 14
description: Assessment of rescue product use (number of times the rescue product was used); comparison among groups, at Day 14.
arm group label: GROUP A: Medical Device Procto
arm group type: Experimental
description: Medical device Procto presents itself as a translucent green gel with a typical smell; it is intended for topical use.
Posology: external or internal use by means of the provided rectal applicator and following the instructions on the package insert. It can be applied when needed, after intimate cleansing, at any time.
arm group label: GROUP B: Matching placebo
arm group type: Placebo Comparator
description: Investigational Product (IP) placebo presents itself as a translucent green gel with a typical smell; it is intended for topical use.
Posology: external or internal use by means of the provided rectal applicator and following the instructions on the package insert. It can be applied when needed, after intimate cleansing, at any time.
intervention type: Device
intervention name: Medical device Procto
description: Medical device Procto presents itself as a translucent green gel with a typical smell.
arm group label: GROUP A: Medical Device Procto
intervention type: Device
intervention name: Matching placebo
description: IP placebo presents itself as a translucent green gel with a typical smell.
arm group label: GROUP B: Matching placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor