A New Class IIb MD in Proctological Disorders

Study Overview
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Brief Summary
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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 reporting symptoms of hemorrhoids (grade 1-3), anal fissures and proctitides.

Official Title
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Evaluation of Performance and Safety of a New Medical Device Class IIb Not Yet CE Marked in Proctological Disorders: a Randomised, Double-blind, Parallel-groups, Multicentric, Placebo-controlled, Prospective Clinical Study.

Conditions
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Proctological Disorders

Intervention / Treatment
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* Device: Medical device Procto
* Device: Matching placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a randomised, double-blind, parallel-groups, multicentric, placebo-controlled, prospective clinical study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GROUP A: Medical Device Procto<br>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<br>* Medical device Procto presents itself as a translucent green gel with a typical smell.<br>|
| Placebo Comparator: GROUP B: Matching placebo<br>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<br>* IP placebo presents itself as a translucent green gel with a typical smell.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | Assessments done by Investigator of overall improvement by means of Global Assessment of Improvement (GAI - according to a 7-grade scoring system, 0-6); comparison between groups, at Day 14. | from Day 0 to Day 14 | 
| Self-assessment of subjective symptoms | Self-assessment of subjective symptoms (anal pain, pain or discomfort during evacuation, itching, irritation or inflammation, bleeding) by means of 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 | 
| Self-assessment of overall treatment | Self-assessment of overall treatment by means of Overall Treatment Evaluation (OTE - according to a 15-point scale; from -7 to -1 = worse; 0 = no change; from +1 to +7 = better); comparison between groups, at Day 14. | from Day 0 to Day 14 | 
| Patient willingness | Patient willingness to use the product in the future, assessed on 1 - 4 points scale (strongly disagree=1, disagree=2, agree=3, strongly agree=4); comparison between groups, at Day 14. | from Day 0 to Day 14 | 
| Assessment of rescue product | Assessment of rescue product use (starting date the rescue product was used); comparison among groups, at Day 14. | from Day 0 to Day 14 | 
| Assessment of rescue product | Assessment of rescue product use (number of times the rescue product was used); comparison among groups, at Day 14. | from Day 0 to Day 14 |