The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure

January 15, 2021 updated by: Gian Luca Baiocchi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Evaluate the effectiveness of fitostimoline proctogel in the anal fissure healing and in the need for invasive interventions (primary endpoints) and in the healing of the fissure (secondary endpoint) using Fitostimoline in addition to or without other topical devices available on the market.

Three groups will be established: one for the exclusive use of fitostimoline, the second for the use of fitostimoline in addition to one of the other topical devices already on the market and the third group only for the use of other topical therapies.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • None previous therapies for anal fissure
  • Symptomatic anal fistula
  • Signing of informed consent
  • age >18 years old

Exclusion Criteria:

  • Patients unable to complete the questionnaire and with a legal guardian.
  • Patients with concomitant abscess/fistula
  • Pregnant women

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fitostimoline proctogel
Device: Fitostimoline proctogel
Medical device for topical use for the treatment of fissures
Other Names:
  • muscle relaxant
Device: Fitostimoline proctogel + muscle relaxant
medical device for topical use for the treatment of fissures
Experimental: fitostimoline proctogel + muscle relaxants
Device: Fitostimoline proctogel
Medical device for topical use for the treatment of fissures
Other Names:
  • muscle relaxant
Device: Fitostimoline proctogel + muscle relaxant
medical device for topical use for the treatment of fissures
Experimental: muscle relaxants
Device: Fitostimoline proctogel
Medical device for topical use for the treatment of fissures
Other Names:
  • muscle relaxant
Device: Fitostimoline proctogel + muscle relaxant
medical device for topical use for the treatment of fissures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
control of anal fissure symptoms
Time Frame: 30 days
pain relief (by using the NRS scale from 0 to 10 (0=absence of pain 10= maximum presence of pain) which should be lower than 3)
30 days
need of invasive treatment
Time Frame: 30 days
Anal dilatation, lateral internal sphincterotomy
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anal fissure healing
Time Frame: 30 days
no pain (NRS scale < 1, where 0 is absence of pain and 10 is maximum pain), no bleeding
30 days

Collaborators and Investigators

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

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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 (Anticipated)

February 10, 2021

Primary Completion (Anticipated)

February 10, 2022

Study Completion (Anticipated)

February 10, 2022

Study Registration Dates

First Submitted

November 27, 2020

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FITOSTIMOLINE

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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