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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

Tracking Information
First Submitted Date  ICMJE February 1, 2019
First Posted Date  ICMJE February 6, 2019
Last Update Posted Date March 2, 2020
Actual Study Start Date  ICMJE August 22, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
Assessment of symptoms according to the Proctological Symptom Scale [ Time Frame: from Day 0 to Day 14 ]
Assessment of symptoms according to the Proctological Symptom Scale - PSS (according to 4 100 mm Visual Analogue Scales; from "no symptoms" to "overwhelming symptoms); comparison between groups, from Day 0 to Day 14
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Assessment of rescue product [ Time Frame: from Day 0 to Day 14 ]
    Assessment of rescue product use (starting date and number of times the rescue product was used); comparison among groups, at Day 14.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A New Class IIb MD in Proctological Disorders
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Proctological Disorders
Intervention  ICMJE
  • Device: Medical device Procto
    Medical device Procto presents itself as a translucent green gel with a typical smell.
  • Device: Matching placebo
    IP placebo presents itself as a translucent green gel with a typical smell.
Study Arms  ICMJE
  • 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.

    Intervention: Device: Medical device Procto
  • 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.

    Intervention: Device: Matching placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2019)
118
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Antonio Bertolino, PhD +390249530065 antonio.bertolino@evidilya.com
Contact: Cesare Mutti cesare.mutti@evidilya.com
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03833076
Other Study ID Numbers  ICMJE ProctoMD01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nathura S.p.A
Study Sponsor  ICMJE Nathura S.p.A
Collaborators  ICMJE Evidilya S.r.l.
Investigators  ICMJE Not Provided
PRS Account Nathura S.p.A
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP