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A New Class IIb MD in Proctological Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03833076
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : March 2, 2020
Sponsor:
Collaborator:
Evidilya S.r.l.
Information provided by (Responsible Party):
Nathura S.p.A

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.

Condition or disease Intervention/treatment Phase
Proctological Disorders Device: Medical device Procto Device: Matching placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a randomised, double-blind, parallel-groups, multicentric, placebo-controlled, prospective clinical study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

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.

Device: Medical device Procto
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.

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833076


Contacts
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Contact: Antonio Bertolino, PhD +390249530065 antonio.bertolino@evidilya.com
Contact: Cesare Mutti cesare.mutti@evidilya.com

Locations
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Italy
Isituto Clinico Humanitas Recruiting
Rozzano, Milano, Italy, 20089
Contact: Antonino Spinelli, Prof    +390282247776    antonino.spinelli@humanitas.it   
Contact: Annalisa Maroli    +390282247776      
Sponsors and Collaborators
Nathura S.p.A
Evidilya S.r.l.

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Responsible Party: Nathura S.p.A
ClinicalTrials.gov Identifier: NCT03833076    
Other Study ID Numbers: ProctoMD01
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Pathologic Processes