Back to resultsEffectiveness & Safety of Neofitoroid® in Hemorrhoidal Disease
Primary Purpose
Hemorrhoids
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Neofitoroid®
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoids
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Patologie del Tratto Alimentare, S. Orsola-Malpighi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neofitoroid®
Arm Description
Treatment is made by the application of Neofitoroid® 2 times a day for 10 days.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Relief in discomfort symptom at 3 and 7 days of treatment compared to baseline (pretreatment).
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
Relief in pain symptom at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
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
Relief in itching at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
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
Relief in burning at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
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
Absolute reduction of discomfort pre and post defecation at 3, 7, and 10 days of treatment compared to baseline (pretreatment).
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.
Reduction of bleeding at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
To evaluate the Reduction of bleeding as measured by a 6 point scale (never, rarely, sometimes, often, very often, always) for bleeding.
Reduction of anal leakage at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
To evaluate the Reduction of anal leakage measured by a 6 point scale (never, rarely, sometimes, often, very often, always) for bleeding
Evaluation of presence of prolapse and/or nodules after 10 days of treatment compared to baseline (if present)
To evaluate the Presence of prolapse and/or nodules after 10 days of treatment
Subject quality of life (EQ-5D-5L improvement after 10 days of treatment compared to baseline (pretreatment).
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.
Full Information
NCT ID
NCT03545724
First Posted
May 21, 2018
Last Updated
May 29, 2019
Sponsor
Aboca Spa Societa' Agricola
Collaborators
GB Pharma Group
1. Study Identification
Unique Protocol Identification Number
NCT03545724
Brief Title
Effectiveness & Safety of Neofitoroid® in Hemorrhoidal Disease
Official Title
Prospective, Single Arm, Open Study to Evaluate the Effect of NeoFitoroid® in Reducing Symptoms in Patients With Hemorrhoidal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
November 19, 2018 (Actual)
Study Completion Date
May 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aboca Spa Societa' Agricola
Collaborators
GB Pharma Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the effect and safety of NeoFitoroid® in reducing symptoms in patients with hemorrhoidal disease.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neofitoroid®
Arm Type
Experimental
Arm Description
Treatment is made by the application of Neofitoroid® 2 times a day for 10 days.
Intervention Type
Device
Intervention Name(s)
Neofitoroid®
Other Intervention Name(s)
Rescue therapy
Intervention Description
NeoFitoroid® forms a protective barrier mucosa and on perianal region that can aid the physiological process of healing.
Primary Outcome Measure Information:
Title
To evaluate the effect of Neofitoroid® in relieving discomfort symptoms after 10 days of treatment compared to baseline (pretreatment).
Description
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
Time Frame
day 10 vs day 0
Secondary Outcome Measure Information:
Title
Relief in discomfort symptom at 3 and 7 days of treatment compared to baseline (pretreatment).
Description
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
Time Frame
day 3 and day 7 vs day 0
Title
Relief in pain symptom at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
Description
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
Time Frame
day 3, day 7 and day 10 vs day 0
Title
Relief in itching at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
Description
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
Time Frame
day 3, day 7 and day 10 vs day 0
Title
Relief in burning at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
Description
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
Time Frame
day 3, day 7 and day 10 vs day 0
Title
Absolute reduction of discomfort pre and post defecation at 3, 7, and 10 days of treatment compared to baseline (pretreatment).
Description
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.
Time Frame
day 3, day 7 and day 10 vs day 0
Title
Reduction of bleeding at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
Description
To evaluate the Reduction of bleeding as measured by a 6 point scale (never, rarely, sometimes, often, very often, always) for bleeding.
Time Frame
day 3, day 7 and day 10 vs day 0
Title
Reduction of anal leakage at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
Description
To evaluate the Reduction of anal leakage measured by a 6 point scale (never, rarely, sometimes, often, very often, always) for bleeding
Time Frame
day 3, day 7 and day 10 vs day 0
Title
Evaluation of presence of prolapse and/or nodules after 10 days of treatment compared to baseline (if present)
Description
To evaluate the Presence of prolapse and/or nodules after 10 days of treatment
Time Frame
day 10 vs day 0
Title
Subject quality of life (EQ-5D-5L improvement after 10 days of treatment compared to baseline (pretreatment).
Description
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.
Time Frame
day 10 vs day 0
Other Pre-specified Outcome Measures:
Title
Assessment on number of defecation at day 0, 3, 7 and 10.
Description
To evaluate the Assessment on number of defecation
Time Frame
day 3, day 7 and day 10 vs day 0
Title
Assessment on type of defecation at day 0, 3, 7 and 10.
Description
To evaluate the Assessment on type of defecation (normal, constipated or diarrheal)
Time Frame
day 3, day 7 and day 10 vs day 0
Title
Assessment of number of relapses between end of treatment and day 31
Description
To evaluate the Number of relapses assessed between end of treatment and day 31, through patient telephone interview.
Time Frame
day 31 vs day 10
Title
Safety and tolerability: analysis of adverse events and serious adverse events
Description
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.
Time Frame
from day -7 to day 31
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Facility Information:
Facility Name
Patologie del Tratto Alimentare, S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness & Safety of Neofitoroid® in Hemorrhoidal Disease
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