Effectiveness & Safety of Neofitoroid® in Hemorrhoidal Disease

NCT03545724 | Completed

• 1 other identifier: ABO-NFT-17
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of Neofitoroid® in relieving discomfort symptoms after 10 days of treatment compared to baseline (pretreatment).

  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

  day 10 vs day 0

Secondary Outcomes (9)

• Relief in discomfort symptom at 3 and 7 days of treatment compared to baseline (pretreatment).

  day 3 and day 7 vs day 0

• Relief in pain symptom at 3, 7 and 10 days of treatment compared to baseline (pretreatment).

  day 3, day 7 and day 10 vs day 0

• Relief in itching at 3, 7 and 10 days of treatment compared to baseline (pretreatment).

  day 3, day 7 and day 10 vs day 0

• Relief in burning at 3, 7 and 10 days of treatment compared to baseline (pretreatment).

  day 3, day 7 and day 10 vs day 0

• Absolute reduction of discomfort pre and post defecation at 3, 7, and 10 days of treatment compared to baseline (pretreatment).

  day 3, day 7 and day 10 vs day 0

Other Outcomes (4)

• Assessment on number of defecation at day 0, 3, 7 and 10.

  day 3, day 7 and day 10 vs day 0

• Assessment on type of defecation at day 0, 3, 7 and 10.

  day 3, day 7 and day 10 vs day 0

• Assessment of number of relapses between end of treatment and day 31

  day 31 vs day 10

Study Arms (1)

Neofitoroid®

EXPERIMENTAL

Treatment is made by the application of Neofitoroid® 2 times a day for 10 days.

Device: Neofitoroid®

Interventions

Neofitoroid® DEVICE

NeoFitoroid® forms a protective barrier mucosa and on perianal region that can aid the physiological process of healing.

Also known as: Rescue therapy

Neofitoroid®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes ≥ 18 years .
• Diagnosis of hemorrhoidal disease of grade I or II, non thrombosed, according to Goligher's classification performed by anoscopy/rectoscopy at screening.
• 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 .
• 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.
• Women of childbearing potential undergone a negative pregnancy test.
• 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.

You may not qualify if:

• Patients with gastrointestinal disease like inflammatory bowel disease, celiac disease, colo-rectal cancer, perianal/fistulizing disease).
• 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.
• Patients with active cancer.
• Tubercolosis , mycosis, Herpes Symplex, virologic disease with anal or perianal skin localization.
• Presence of physical and/or mental disability that reduces the ability to take medicines as expected.
• Concomitant abuse of drugs or alcohol.
• No adequate reliability or presence of conditions that may result in non-compliance / adherence of the patient to the Protocol.
• 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.
• 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.
• Subjects with the presence of alarm symptoms (weight loss, lack of appetite).
• Prior use of other topical ointment for the treatment of haemorrhoid within 14 days before enrollment.
• Pregnant and/or breastfeeding patients.
• Participation in interventional research studies of investigational medicinal or device products (ongoing or terminated less than 30 days before screening).

Sponsors & Collaborators

• Aboca Spa Societa' Agricola: lead
• GB Pharma Group: collaborator

Study Sites (1)

Patologie del Tratto Alimentare, S. Orsola-Malpighi

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Assignment

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 4, 2018
• Study Start: February 7, 2018
• Primary Completion: November 19, 2018
• Study Completion: May 16, 2019
• Last Updated: May 30, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)