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

NCT ID: NCT04714684

Last Updated: 2021-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2022-02-10

Brief Summary

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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.

Detailed Description

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Conditions

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Fissure in Ano

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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fitostimoline proctogel

Group Type EXPERIMENTAL

Fitostimoline proctogel

Intervention Type DEVICE

Medical device for topical use for the treatment of fissures

Fitostimoline proctogel + muscle relaxant

Intervention Type DEVICE

medical device for topical use for the treatment of fissures

fitostimoline proctogel + muscle relaxants

Group Type EXPERIMENTAL

Fitostimoline proctogel

Intervention Type DEVICE

Medical device for topical use for the treatment of fissures

Fitostimoline proctogel + muscle relaxant

Intervention Type DEVICE

medical device for topical use for the treatment of fissures

muscle relaxants

Group Type EXPERIMENTAL

Fitostimoline proctogel

Intervention Type DEVICE

Medical device for topical use for the treatment of fissures

Fitostimoline proctogel + muscle relaxant

Intervention Type DEVICE

medical device for topical use for the treatment of fissures

Interventions

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Fitostimoline proctogel

Medical device for topical use for the treatment of fissures

Intervention Type DEVICE

Fitostimoline proctogel + muscle relaxant

medical device for topical use for the treatment of fissures

Intervention Type DEVICE

Other Intervention Names

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muscle relaxant

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Gian Luca Baiocchi

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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FITOSTIMOLINE

Identifier Type: -

Identifier Source: org_study_id

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