Fissure in AnoNCT04714684
The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure
A study testing Fitostimoline proctogel and Fitostimoline proctogel + muscle relaxant in people with Fissure in Ano, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fissure in Ano
- What is being tested?
- Fitostimoline proctogel and Fitostimoline proctogel + muscle relaxant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2021to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- None previous therapies for anal fissure
- Symptomatic anal fistula
- Signing of informed consent
- age >18 years old
Who cannot join
- Patients unable to complete the questionnaire and with a legal guardian.
- Patients with concomitant abscess/fistula
- Pregnant women
About this study
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.
- Conditions
- Fissure in Ano
- Being tested
- Fitostimoline proctogel, Fitostimoline proctogel + muscle relaxant
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitostimoline proctogelDevice
Also called muscle relaxant
Medical device for topical use for the treatment of fissures
Fitostimoline proctogel + muscle relaxantDevice
medical device for topical use for the treatment of fissures
| Study group | Role | What they receive |
|---|---|---|
| fitostimoline proctogel | Experimental | Not described Receives: Device: Fitostimoline proctogel; Device: Fitostimoline proctogel + muscle relaxant |
| fitostimoline proctogel + muscle relaxants | Experimental | Not described Receives: Device: Fitostimoline proctogel; Device: Fitostimoline proctogel + muscle relaxant |
| muscle relaxants | Experimental | Not described Receives: Device: Fitostimoline proctogel; Device: Fitostimoline proctogel + muscle relaxant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
need of invasive treatment
Anal dilatation, lateral internal sphincterotomy
Measured: 30 days
Secondary outcomes (1)
anal fissure healing
no pain (NRS scale < 1, where 0 is absence of pain and 10 is maximum pain), no bleeding
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start10 Feb 2021 (estimated)
- Primary completion10 Feb 2022 (estimated)
- Study completion10 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fissure in AnoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gian Luca Baiocchi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714684
- Sponsor's protocol ID
- FITOSTIMOLINE
- Status last verified
- Jan 2021
- First submitted
- 27 Nov 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure
- ClinicalTrials.gov ID
- NCT04714684
- Acronym / sponsor ID
- FITOSTIMOLINE
- Conditions
- Fissure in Ano
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 10 Feb 2021 (estimated)
- Primary completion
- 10 Feb 2022 (estimated)
- Study completion
- 10 Feb 2022 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fitostimoline proctogel | Experimental | Device: Fitostimoline proctogel, Device: Fitostimoline proctogel + muscle relaxant |
| fitostimoline proctogel + muscle relaxants | Experimental | Device: Fitostimoline proctogel, Device: Fitostimoline proctogel + muscle relaxant |
| muscle relaxants | Experimental | Device: Fitostimoline proctogel, Device: Fitostimoline proctogel + muscle relaxant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- None previous therapies for anal fissure
- Symptomatic anal fistula
- Signing of informed consent
- age >18 years old
Key exclusion criteria (3 listed)
- Patients unable to complete the questionnaire and with a legal guardian.
- Patients with concomitant abscess/fistula
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitostimoline proctogelAlso: muscle relaxantMedical device for topical use for the treatment of fissures | Device | fitostimoline proctogel, fitostimoline proctogel + muscle relaxants, muscle relaxants |
| Fitostimoline proctogel + muscle relaxantmedical device for topical use for the treatment of fissures | Device | fitostimoline proctogel, fitostimoline proctogel + muscle relaxants, muscle relaxants |
Primary outcome
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)
need of invasive treatment
Time frame: 30 days
Anal dilatation, lateral internal sphincterotomy
1 secondary outcome
anal fissure healing
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fitostimoline proctogel and Fitostimoline proctogel + muscle relaxant in people with Fissure in Ano, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
control of anal fissure symptoms (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.