A New Class IIb MD in Proctological Disorders

NCT03833076 | Completed

• 1 other identifier: ProctoMD01
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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

Conditions

Proctological Disorders

Outcome Measures

Primary Outcomes (1)

• 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 (7)

• Investigator's assessment of signs

  from Day 0 to Day 14

• Assessments done by Investigator of overall improvement

  from Day 0 to Day 14

• Self-assessment of subjective symptoms

  from Day 0 to Day 14

• Self-assessment of overall treatment

  from Day 0 to Day 14

• Patient willingness

  from Day 0 to Day 14

Study Arms (2)

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

Medical device Procto DEVICE

Medical device Procto presents itself as a translucent green gel with a typical smell.

GROUP A: Medical Device Procto

Matching placebo DEVICE

IP placebo presents itself as a translucent green gel with a typical smell.

GROUP B: Matching placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nathura S.p.A: lead
• Evidilya S.r.l.: collaborator

Study Sites (1)

Isituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: a randomised, double-blind, parallel-groups, multicentric, placebo-controlled, prospective clinical study

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 6, 2019
• Study Start: August 22, 2019
• Primary Completion: November 27, 2020
• Study Completion: November 27, 2020
• Last Updated: December 23, 2020

Record last verified: 2020-12

Locations

IT (1)