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Effectiveness & Safety of Neofitoroid® in Hemorrhoidal Disease

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ClinicalTrials.gov Identifier: NCT03545724
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
GB Pharma Group
Information provided by (Responsible Party):
Aboca Spa Societa' Agricola

Brief Summary:
Evaluation of the effect and safety of NeoFitoroid® in reducing symptoms in patients with hemorrhoidal disease.

Condition or disease Intervention/treatment Phase
Hemorrhoids Device: Neofitoroid® Not Applicable

Detailed Description:

Evaluation of the effect and safety of NeoFitoroid® in relieving discomfort symptom after 10 days of treatment compared to baseline (pretreatment).

The study duration per patient is 31 days (visit 1 + 10 days treatment + 20 days follow-up).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Single Arm, Open Study to Evaluate the Effect of NeoFitoroid® in Reducing Symptoms in Patients With Hemorrhoidal Disease
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
Experimental: Neofitoroid®
Treatment is made by the application of Neofitoroid® 2 times a day for 10 days.
Device: Neofitoroid®
NeoFitoroid® forms a protective barrier mucosa and on perianal region that can aid the physiological process of healing.
Other Name: Rescue therapy




Primary Outcome Measures :
  1. To evaluate the effect of Neofitoroid® in relieving discomfort symptoms after 10 days of treatment compared to baseline (pretreatment). [ Time Frame: day 10 vs day 0 ]

    Reduction of discomfort symptoms measured through a 0‐100 Visual Analog Scale related to hemorrhoidal discomfort (VAS, from "no symptoms" to "overwhelming symptoms", 100-mm scale) after 10 days of treatment compared to baseline.

    The higher values represent a worse outcome. Primary endpoint will be evaluated only with the hemorrhoidal discomfort VAS



Secondary Outcome Measures :
  1. Relief in discomfort symptom at 3 and 7 days of treatment compared to baseline (pretreatment). [ Time Frame: day 3 and day 7 vs day 0 ]
    To evaluate the Reduction of discomfort symptom measured through a 0‐100 Visual Analog Scale related to hemorrhoidal discomfort (VAS, from "no symptoms" to "overwhelming symptoms", 100-mm scale). The higher values represent a worse outcome. This secondary endpoint will be evaluated only with the hemorrhoidal discomfort VAS

  2. Relief in pain symptom at 3, 7 and 10 days of treatment compared to baseline (pretreatment). [ Time Frame: day 3, day 7 and day 10 vs day 0 ]
    To evaluate the Reduction of pain symptom measured through a 0‐100 Visual Analog Scale related to hemorrhoidal pain symptom (VAS, from "no symptoms" to "overwhelming symptoms", 100-mm scale). The higher values represent a worse outcome. This secondary endpoint will be evaluated only with the hemorrhoidal pain symptom VAS

  3. Relief in itching at 3, 7 and 10 days of treatment compared to baseline (pretreatment). [ Time Frame: day 3, day 7 and day 10 vs day 0 ]
    Reduction of itching symptoms measured through a 0‐100 Visual Analog Scale related to hemorrhoidal itching (VAS, from "no symptoms" to "overwhelming symptoms",100-mm scale). The higher values represent a worse outcome. This secondary endpoint will be evaluated only with the hemorrhoidal itching VAS

  4. Relief in burning at 3, 7 and 10 days of treatment compared to baseline (pretreatment). [ Time Frame: day 3, day 7 and day 10 vs day 0 ]
    Reduction of burning symptoms measured through a 0‐100 Visual Analog Scale related to hemorrhoidal burning (VAS, from "no symptoms" to "overwhelming symptoms", 100-mm scale). The higher values represent a worse outcome. This secondary endpoint will be evaluated only with the hemorrhoidal burning VAS

  5. Absolute reduction of discomfort pre and post defecation at 3, 7, and 10 days of treatment compared to baseline (pretreatment). [ Time Frame: day 3, day 7 and day 10 vs day 0 ]
    Absolute reduction of discomfort pre and post defecation measured through a 0‐100 Visual Analog Scale related to hemorrhoidal discomfort (VAS, from "no symptoms" to "overwhelming symptoms", 100-mm scale). The higher values represent a worse outcome. This secondary endpoint will be evaluated through a compiled VAS pre-defecation and a compiled VAS post-defecation. This secondary endpoint will be evaluated through mean of the differences (VAS score post-defecation - VAS score pre-defecation) at differents time of study compared to the mean measured at baseline.

  6. Reduction of bleeding at 3, 7 and 10 days of treatment compared to baseline (pretreatment). [ Time Frame: day 3, day 7 and day 10 vs day 0 ]
    To evaluate the Reduction of bleeding as measured by a 6 point scale (never, rarely, sometimes, often, very often, always) for bleeding.

  7. Reduction of anal leakage at 3, 7 and 10 days of treatment compared to baseline (pretreatment). [ Time Frame: day 3, day 7 and day 10 vs day 0 ]
    To evaluate the Reduction of anal leakage measured by a 6 point scale (never, rarely, sometimes, often, very often, always) for bleeding

  8. Evaluation of presence of prolapse and/or nodules after 10 days of treatment compared to baseline (if present) [ Time Frame: day 10 vs day 0 ]
    To evaluate the Presence of prolapse and/or nodules after 10 days of treatment

  9. Subject quality of life (EQ‐5D‐5L improvement after 10 days of treatment compared to baseline (pretreatment). [ Time Frame: day 10 vs day 0 ]
    To evaluate the Quality of life improvement measured with Quality of Life Index (EQ‐5D‐5L, MOVEMENT CAPACITY, PERSONAL CARE, LIVING ACTIVITIES, PAIN OR DISCOMFORT, ANXIETY OR DEPRESSION). The higher values represent a worse outcome.


Other Outcome Measures:
  1. Assessment on number of defecation at day 0, 3, 7 and 10. [ Time Frame: day 3, day 7 and day 10 vs day 0 ]
    To evaluate the Assessment on number of defecation

  2. Assessment on type of defecation at day 0, 3, 7 and 10. [ Time Frame: day 3, day 7 and day 10 vs day 0 ]
    To evaluate the Assessment on type of defecation (normal, constipated or diarrheal)

  3. Assessment of number of relapses between end of treatment and day 31 [ Time Frame: day 31 vs day 10 ]
    To evaluate the Number of relapses assessed between end of treatment and day 31, through patient telephone interview.

  4. Safety and tolerability: analysis of adverse events and serious adverse events [ Time Frame: from day -7 to day 31 ]
    To evaluate safety and tolerability of NeoFitoroid® through the analysis of adverse events and serious adverse events that will be recorded throughout the duration of the study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of both sexes ≥ 18 years .
  2. Diagnosis of hemorrhoidal disease of grade I or II, non thrombosed, according to Goligher's classification performed by anoscopy/rectoscopy at screening.
  3. Patient is not expected to require non‐pharmacological (as Sclerotherapy, Rubber band ligation, Infrared Coagulation, Radiofrequency Ablation, Cryotherapy) or surgical treatment in the 31 days post enrollment .
  4. Discomfort score related to the hemorrhoidal disease ≥ 30 measured through a 0‐100 Visual Analog Scale VAS (from "no symptoms" to "overwhelming symptoms") at screening.
  5. Women of childbearing potential undergone a negative pregnancy test.
  6. Informed consent documentation signed and dated confirming that the patient has been adequately informed of all aspects related to his/her participation in the clinical study and is willing to participate.

Exclusion Criteria:

  1. Patients with gastrointestinal disease like inflammatory bowel disease, celiac disease, colo‐rectal cancer, perianal/fistulizing disease).
  2. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and/or that, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  3. Patients with active cancer.
  4. Tubercolosis , mycosis, Herpes Symplex, virologic disease with anal or perianal skin localization.
  5. Presence of physical and/or mental disability that reduces the ability to take medicines as expected.
  6. Concomitant abuse of drugs or alcohol.
  7. No adequate reliability or presence of conditions that may result in non‐compliance / adherence of the patient to the Protocol.
  8. Subjects with known or suspected allergy to plants of Helichrysum family, aloe vera, Ruscus, Hypericum, Jojoba Oil, Shea Butter, Essential oils of: Melaleuca, Cypress and Peppermint.
  9. Subjects with known or suspected allergy to ingredients such as: glicerilstearato, Caprylic / capric, sucrose distearate, sucrose stearate, cetearyl alcohol, vegetable glycerin, triidrossistearina, vegetable oils, hydrogenated vegetable oils, Candelilla wax, xanthan gum, citric acid, tocopherols, sodium silicate, benzyl alcohol, potassium sorbate, sodium dehydroacetate, Sunflower oil.
  10. Subjects with the presence of alarm symptoms (weight loss, lack of appetite).
  11. Prior use of other topical ointment for the treatment of haemorrhoid within 14 days before enrollment.
  12. Pregnant and/or breastfeeding patients.
  13. Participation in interventional research studies of investigational medicinal or device products (ongoing or terminated less than 30 days before screening).

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): NCT03545724


Contacts
Contact: Andrea Cossu, MD +39 3668331464 acossu@aboca.it

Locations
Italy
Patologie del Tratto Alimentare, S. Orsola-Malpighi Recruiting
Bologna, Italy, 40138
Contact: Gilberto Poggiolli, Prof       gilberto.poggioli@unibo.it   
Contact: Matteo Rottoli, Dr       matteo.rottoli2@unibo.it   
Sponsors and Collaborators
Aboca Spa Societa' Agricola
GB Pharma Group

Responsible Party: Aboca Spa Societa' Agricola
ClinicalTrials.gov Identifier: NCT03545724     History of Changes
Other Study ID Numbers: ABO-NFT-17
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases