Study Results
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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COMPLETED
NA
118 participants
INTERVENTIONAL
2019-08-22
2020-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Medical device Procto presents itself as a translucent green gel with a typical smell.
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.
Matching placebo
IP placebo presents itself as a translucent green gel with a typical smell.
Interventions
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Medical device Procto
Medical device Procto presents itself as a translucent green gel with a typical smell.
Matching placebo
IP placebo presents itself as a translucent green gel with a typical smell.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Evidilya S.r.l.
INDUSTRY
Nathura S.p.A
INDUSTRY
Responsible Party
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Locations
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Isituto Clinico Humanitas
Rozzano, Milano, Italy
Countries
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Other Identifiers
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ProctoMD01
Identifier Type: -
Identifier Source: org_study_id
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