A New Class IIb MD in Proctological Disorders | NCT03833076

NCT03833076

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Evidilya S.r.l.	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GROUP A: Medical Device Procto	Experimental	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.	Device: Medical device Procto
GROUP B: Matching placebo	Placebo Comparator	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.	Device: Matching placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical device Procto	Device	Medical device Procto presents itself as a translucent green gel with a typical smell.	GROUP A: Medical Device Procto

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of symptoms according to the Proctological Symptom Scale (PSS)	Assessment of symptoms according to the Proctological Symptom Scale - PSS (according to 100 mm Visual Analogue Scales; from "no symptoms" to "overwhelming symptoms); comparison between groups, from Day 0 to Day 14	from Day 0 to Day 14

Secondary Outcomes

Measure	Description	Time Frame
Investigator's assessment of signs	Investigator's assessment of signs: anal pain, inflammation and visible bleeding, categorized as none, mild, moderate, or severe (corresponding to a score of 0, 1, 2 or 3, respectively); comparison between groups, from Day 0 to Day 14.	from Day 0 to Day 14
Assessments done by Investigator of overall improvement

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.