A New Class IIb MD in Proctological Disorders

December 22, 2020 updated by: Nathura S.p.A

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.

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Milano
      • Rozzano, Milano, Italy, 20089
        • Isituto Clinico Humanitas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients of both sexes aged between 18 and 75 years.
  2. Patients reporting symptoms of haemorrhoids (grade 1-3*), anal fissures and proctitides or already diagnosed with haemorrhoids (grade 1-3), anal fissures and proctitides; diagnosis confirmed by proctological examination at Screening Visit.

    *Grade 1 - Haemorrhoid protrudes into the anal canal but does not prolapse outside the anus.

    Grade 2 - Haemorrhoid protrudes through the anus during straining or evacuation but returns spontaneously.

    Grade 3 - Haemorrhoid protrudes through the anus during straining or evacuation but needs to be manually returned to position.

    Grade 4 - Haemorrhoid remains prolapsed outside of the anus.

  3. Patients agreeing not to use any other systemic or topic medicinal / product to treat haemorrhoids, anal fissures and proctitides during the study and not to modify their personal hygiene products.
  4. Female patients of childbearing potential following a reliable contraceptive method (according to Investigator's opinion).
  5. Willingness to participate in the study and to sign an informed consent form.

Exclusion Criteria:

  1. Patients presenting infective anal or rectal pathologies (in particular bacterial infections associated with proctitides or proctitides caused by viral infections).
  2. Patients presenting complicated haemorrhoids.
  3. Patients with Crohn's disease or malignancy.
  4. Patients presenting undiagnosed abnormal rectal bleeding.
  5. Patients with known or suspected rectal hypersensitivity.
  6. Patients presenting coagulation disorders or on anticoagulant drug therapy (except clopidogrel or acetylsalicylic acid).
  7. Patients in treatment with topic or systemic medications / products to treat haemorrhoids, fissures and proctitides, currently or in the 2 weeks prior to Screening Visit.
  8. Patients using laxatives or stool softener currently or in the 2 weeks prior to Screening Visit.
  9. Patients pregnant or breastfeeding.
  10. Patients reporting past or present narcotic addiction or alcoholism.
  11. Patients that participated in any other clinical trial during the last month or participating in any clinical trial while participating in this trial.
  12. Patients reporting allergy or intolerance to any component of test product, placebo or rescue product.
  13. Patients who in the opinion of the principal Investigator are at risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trial.
  14. Patients presenting contraindications to Proktis-M (rescue product), according to concerning leaflet.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GROUP A: Medical Device Procto

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.

Medical device Procto presents itself as a translucent green gel with a typical smell.
PLACEBO_COMPARATOR: GROUP B: Matching placebo

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.

IP placebo presents itself as a translucent green gel with a typical smell.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of symptoms according to the Proctological Symptom Scale (PSS)
Time Frame: from Day 0 to Day 14
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
from Day 0 to Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator's assessment of signs
Time Frame: from Day 0 to Day 14
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.
from Day 0 to Day 14
Assessments done by Investigator of overall improvement
Time Frame: from Day 0 to Day 14
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.
from Day 0 to Day 14
Self-assessment of subjective symptoms
Time Frame: from Day 0 to Day 14
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.
from Day 0 to Day 14
Self-assessment of overall treatment
Time Frame: from Day 0 to Day 14
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.
from Day 0 to Day 14
Patient willingness
Time Frame: from Day 0 to Day 14
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.
from Day 0 to Day 14
Assessment of rescue product
Time Frame: from Day 0 to Day 14
Assessment of rescue product use (starting date the rescue product was used); comparison among groups, at Day 14.
from Day 0 to Day 14
Assessment of rescue product
Time Frame: from Day 0 to Day 14
Assessment of rescue product use (number of times the rescue product was used); comparison among groups, at Day 14.
from Day 0 to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 22, 2019

Primary Completion (ACTUAL)

November 27, 2020

Study Completion (ACTUAL)

November 27, 2020

Study Registration Dates

First Submitted

February 1, 2019

First Submitted That Met QC Criteria

February 5, 2019

First Posted (ACTUAL)

February 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 23, 2020

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProctoMD01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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