HemorrhoidsNCT03545724
Effectiveness & Safety of Neofitoroid® in Hemorrhoidal Disease
A study testing Neofitoroid® in people with Hemorrhoids, run by Aboca Spa Societa' Agricola at 1 site in Italy.
Trial summary
Evaluation of the effect and safety of NeoFitoroid® in reducing symptoms in patients with hemorrhoidal disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Neofitoroid®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 7 Feb 2018to 16 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Single Arm, Open Study to Evaluate the Effect of NeoFitoroid® in Reducing Symptoms in Patients With Hemorrhoidal Disease
Evaluation of the effect and safety of NeoFitoroid® in reducing symptoms in patients with hemorrhoidal disease.
Read the 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).
- Conditions
- Hemorrhoids
- Being tested
- Neofitoroid®
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neofitoroid®Device
Also called Rescue therapy
NeoFitoroid® forms a protective barrier mucosa and on perianal region that can aid the physiological process of healing.
| Study group | Role | What they receive |
|---|---|---|
| Neofitoroid® | Experimental | Treatment is made by the application of Neofitoroid® 2 times a day for 10 days. Receives: Device: Neofitoroid® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 10 vs day 0
Secondary outcomes (9)
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
Measured: day 3 and day 7 vs day 0
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
Measured: 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).
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
Measured: 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).
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
Measured: 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).
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.
Measured: day 3, day 7 and day 10 vs day 0
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.
Measured: day 3, day 7 and day 10 vs day 0
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
Measured: day 3, day 7 and day 10 vs day 0
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
Measured: day 10 vs day 0
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.
Measured: day 10 vs day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start7 Feb 2018
- Primary completion19 Nov 2018
- Study completion16 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Assignment
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aboca Spa Societa' Agricola
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GB Pharma Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545724
- Sponsor's protocol ID
- ABO-NFT-17
- Status last verified
- May 2018
- First submitted
- 21 May 2018
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm, Open Study to Evaluate the Effect of NeoFitoroid® in Reducing Symptoms in Patients With Hemorrhoidal Disease
- ClinicalTrials.gov ID
- NCT03545724
- Acronym / sponsor ID
- ABO-NFT-17
- Conditions
- Hemorrhoids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Aboca Spa Societa' AgricolaIndustry (pharma, biotech, devices)
- Collaborators
- GB Pharma Group
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Neofitoroid® | Experimental | Device: Neofitoroid®Treatment is made by the application of Neofitoroid® 2 times a day for 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neofitoroid®Also: Rescue therapyNeoFitoroid® forms a protective barrier mucosa and on perianal region that can aid the physiological process of healing. | Device | Neofitoroid® |
Primary outcome
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
9 secondary outcomes
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
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
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
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
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
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
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
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
Subject quality of life (EQ-5D-5L improvement after 10 days of treatment compared to baseline (pretreatment).
Time frame: day 10 vs day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neofitoroid® in people with Hemorrhoids, run by Aboca Spa Societa' Agricola at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.