- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03833076
A New Class IIb MD in Proctological Disorders
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Milano
-
Rozzano, Milano, Italy, 20089
- Isituto Clinico Humanitas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: GROUP A: Medical Device Procto
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. |
Medical device Procto presents itself as a translucent green gel with a typical smell.
|
PLACEBO_COMPARATOR: GROUP B: Matching placebo
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. |
IP placebo presents itself as a translucent green gel with a typical smell.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of symptoms according to the Proctological Symptom Scale (PSS)
Time Frame: from Day 0 to Day 14
|
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
Time Frame: from Day 0 to Day 14
|
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
Time Frame: from Day 0 to Day 14
|
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
Time Frame: from Day 0 to Day 14
|
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
Time Frame: from Day 0 to Day 14
|
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
Time Frame: from Day 0 to Day 14
|
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
Time Frame: from Day 0 to Day 14
|
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
Time Frame: from Day 0 to Day 14
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ProctoMD01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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