A New Class IIb MD in Proctological Disorders

Nathura

Status: Completed

Conditions: Proctological Disorders

Treatments: Device: Matching placebo; Device: Medical device Procto

Study type: Interventional

Funder types: Industry

Identifiers

NCT03833076

ProctoMD01

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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118 participants in 2 patient groups, including a placebo group

GROUP A: Medical Device Procto

Experimental group

Description:

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.

Treatment:

Device: Medical device Procto

GROUP B: Matching placebo

Placebo Comparator group

Description:

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.

Treatment:

Device: Matching placebo