Status:
COMPLETED
A New Class IIb MD in Proctological Disorders
Lead Sponsor:
Nathura S.p.A
Collaborating Sponsors:
Evidilya S.r.l.
Conditions:
Proctological Disorders
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this study is primarily to investigate the performance of a new medical device not yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult patients repo...
Eligibility Criteria
Inclusion
- Patients of both sexes aged between 18 and 75 years.
- 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.
- 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.
- Female patients of childbearing potential following a reliable contraceptive method (according to Investigator's opinion).
- Willingness to participate in the study and to sign an informed consent form.
Exclusion
- Patients presenting infective anal or rectal pathologies (in particular bacterial infections associated with proctitides or proctitides caused by viral infections).
- Patients presenting complicated haemorrhoids.
- Patients with Crohn's disease or malignancy.
- Patients presenting undiagnosed abnormal rectal bleeding.
- Patients with known or suspected rectal hypersensitivity.
- Patients presenting coagulation disorders or on anticoagulant drug therapy (except clopidogrel or acetylsalicylic acid).
- 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.
- Patients using laxatives or stool softener currently or in the 2 weeks prior to Screening Visit.
- Patients pregnant or breastfeeding.
- Patients reporting past or present narcotic addiction or alcoholism.
- Patients that participated in any other clinical trial during the last month or participating in any clinical trial while participating in this trial.
- Patients reporting allergy or intolerance to any component of test product, placebo or rescue product.
- 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.
- Patients presenting contraindications to Proktis-M (rescue product), according to concerning leaflet.
Key Trial Info
Start Date :
August 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2020
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03833076
Start Date
August 22 2019
End Date
November 27 2020
Last Update
December 23 2020
Active Locations (1)
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1
Isituto Clinico Humanitas
Rozzano, Milano, Italy, 20089