Clinical trial NCT03833076: A New Class IIb MD in Proctological Disorders
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proctological Disorders
Lead sponsor: Nathura S.p.A
Sponsor class: INDUSTRY
Collaborators: name: Evidilya S.r.l.
First posted: 2019-02-06
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomised, double-blind, parallel-groups, multicentric, placebo-controlled, prospective clinical study
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Assessment of symptoms according to the Proctological Symptom Scale (PSS)
timeFrame: from Day 0 to Day 14
Secondary outcomes:
measure: Investigator's assessment of signs
timeFrame: from Day 0 to Day 14
measure: Assessments done by Investigator of overall improvement
timeFrame: from Day 0 to Day 14
measure: Self-assessment of subjective symptoms
timeFrame: from Day 0 to Day 14
measure: Self-assessment of overall treatment
timeFrame: from Day 0 to Day 14
measure: Patient willingness
timeFrame: from Day 0 to Day 14
measure: Assessment of rescue product
timeFrame: from Day 0 to Day 14
measure: Assessment of rescue product
timeFrame: from Day 0 to Day 14
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Isituto Clinico Humanitas
state: Milano
Study officials:
References: