The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2020
CompletedFirst Posted
Study publicly available on registry
January 19, 2021
CompletedStudy Start
First participant enrolled
February 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2022
CompletedJanuary 19, 2021
January 1, 2021
1 year
November 27, 2020
January 15, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
control of anal fissure symptoms
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
Anal dilatation, lateral internal sphincterotomy
30 days
Secondary Outcomes (1)
anal fissure healing
30 days
Study Arms (3)
fitostimoline proctogel
EXPERIMENTALfitostimoline proctogel + muscle relaxants
EXPERIMENTALmuscle relaxants
EXPERIMENTALInterventions
Medical device for topical use for the treatment of fissures
medical device for topical use for the treatment of fissures
Eligibility Criteria
You may qualify if:
- None previous therapies for anal fissure
- Symptomatic anal fistula
- Signing of informed consent
- age \>18 years old
You may not qualify if:
- Patients unable to complete the questionnaire and with a legal guardian.
- Patients with concomitant abscess/fistula
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
November 27, 2020
First Posted
January 19, 2021
Study Start
February 10, 2021
Primary Completion
February 10, 2022
Study Completion
February 10, 2022
Last Updated
January 19, 2021
Record last verified: 2021-01