A New Class IIb MD in Proctological Disorders

Launched by NATHURA S.P.A · Feb 5, 2019

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients of both sexes aged between 18 and 75 years.
• • 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:
• • 1. Patients presenting infective anal or rectal pathologies (in particular bacterial infections associated with proctitides or proctitides caused by viral infections).
• • 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.