- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05788497
Efficacy and Safety of Hemorrane Plus Versus Hemorrane and Versus Placebo in Patients With Uncomplicated Haemorrhoids
February 23, 2024 updated by: Faes Farma, S.A.
Multicentre, Double-blind, Randomised Clinical Trial to Evaluate and Compare the Efficacy and Safety of Hemorrane Plus (Hemorrane® + Benzocaine) With Hemorrane® and With Placebo in Patients With Uncomplicated Haemorrhoids
This is a Multicentre, double-blind, randomised clinical trial to evaluate and compare the efficacy and safety of Hemorrane Plus (Hemorrane® + benzocaine) with Hemorrane® and with placebo in patients with uncomplicated haemorrhoids.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Inmaculada Gilaberte
- Phone Number: +34670222865
- Email: igilaberte@faes.es
Study Locations
-
-
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Madrid, Spain, 28006
- CS Montesa
-
Contact:
- Milagros González, Dra.
-
Principal Investigator:
- Milagros González, Dra.
-
Madrid, Spain, 28009
- CS Goya
-
Contact:
- Ana P. Javierre, Dra.
-
Principal Investigator:
- Ana P. Javierre, Dra.
-
Madrid, Spain, 28044
- CS General Fanjul
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Contact:
- David Dominguez Navarro, Dr.
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Principal Investigator:
- David Dominguez Navarro, Dr.
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Madrid, Spain, 28034
- CS Fuencarral
-
Contact:
- Carmen Valdés y Llorca, Dra.
-
Principal Investigator:
- Carmen Valdés y Llorca, Dra.
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Ávila, Spain, 5001
- CS Ávila Estación
-
Contact:
- Miguel A. Gutierrez, Dr.
-
Principal Investigator:
- Miguel A. Gutierrez, Dr.
-
-
Barcelona
-
Castelldefels, Barcelona, Spain, 08860
- CAP Can Bou
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Contact:
- Nuria Freixenet, Dra.
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Principal Investigator:
- Nuria Freixenet, Dra.
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Corbera de Llobregat, Barcelona, Spain, 08757
- CAP Corbera de Llobregat
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Contact:
- Verónica Gómez, Dra.
-
Principal Investigator:
- Verónica Gómez, Dra.
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L'Hospitalet de Llobregat, Barcelona, Spain, 08028
- CAPSBE Les Corts
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Contact:
- Laura Sebastián, Dra.
-
Principal Investigator:
- Dra. Laura Sebastián
-
-
Comunidad Valenciana
-
Valencia, Comunidad Valenciana, Spain, 46010
- CS Trinitat
-
Contact:
- Jose V. Solanas, Dr.
-
Principal Investigator:
- José V. Solanas, Dr.
-
Valencia, Comunidad Valenciana, Spain, 46023
- CS Trafalgar
-
Contact:
- Ricardo Ortega, Dr.
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Principal Investigator:
- Ricardo Ortega, Dr.
-
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Madrid
-
Leganés, Madrid, Spain, 28914
- CS Dr. Mendiguchia Carriche
-
Contact:
- Juan C. García, Dr.
-
Principal Investigator:
- Juan C. García, Dr.
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Torrejón De Ardoz, Madrid, Spain, 28850
- CS Las Fronteras
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Contact:
- Verónica Molina, Dra.
-
Principal Investigator:
- Verónica Molina, Dra.
-
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Pontevedra
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A Estrada, Pontevedra, Spain, 36680
- CS A Estrada
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Over 18s and both sexes.
- Voluntary signing of informed consent.
- Diagnosis of uncomplicated haemorrhoids: grade I or II non-thrombosed external, mixed, or internal haemorrhoids.
- VAS of pain ≥ 5 points.
- VAS of pruritus and stinging/burning ≥ 5 points (for each one).
- Commitment to comply with the hygienic-dietary measures established for the general management of haemorrhoids.
- Negative urine pregnancy test (women of childbearing age, if applicable).
- Patients with adequate understanding of the study and ability to perform the procedures independently.
Exclusion Criteria:
- History of hypersensitivity to any of the active ingredients or components of the investigational products, as well as hypersensitivity to other local anaesthetics derived from para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (for example, hair dyes, henna tattoos).
- Use of topical haemorrhoid medications or other topical agents for the anorectal area less than 48 hours before the start of the study (Visit 1, day 1).
- Haemorrhoidal surgery that is scheduled between Visit 1 (day 1) and the follow-up visit Visit 3 (day 15±2).
- Diagnosis of grade III or IV thrombosed external or internal haemorrhoids.
- Medical history of anaemia, and/or current diagnosis of cardiac or pulmonary disease, shock, sepsis, acidosis, or genetic predisposition (NADH-cytochrome b5 reductase deficiency, glucose-6-phosphate dehydrogenase deficiency, and haemoglobin M disease); that include risk factors for methemoglobinemia.
- Documented diagnosis of active tuberculosis.
- Active bleeding haemorrhoids.
- Presence of pain, stinging/burning, pruritus, anorectal bleeding or rectal bleeding for causes other than haemorrhoidal disease.
- Presence of bacterial, viral, and/or fungal infections in the perianal area.
- History of pancreatic pathology that may require performance of a bentiromide diagnostic test.
- Use of any of the prohibited concomitant medications (sulfonamides, cholinesterase inhibitors, ester or prilocaine-type local anaesthetics, sodium nitrite, neurotoxic insecticides (topical malathion), aminosalicylic acid, suxamethonium, antiarrhythmics, monoamine oxidase inhibitors, tricyclic antidepressants, and PABA derivatives) less than one week prior to the start of the study (Visit 1, Day 1), or throughout the study.
- Use of any hair dye, including those containing paraphenylene-diamine during the study, from Visit 1 (Day 1) to the follow-up Visit 3 (Day 15 ± 2).
- Any other circumstance considered by the investigator to prevent adequate follow-up and/or adequate evolution of the response to the study treatments.
- Pregnant women, those planning an upcoming pregnancy or breast-feeding.
- Women of childbearing age who do not agree to take the pregnancy test and use valid contraceptive methods during the study and until the end of the use of the investigational treatment. The following are considered valid contraceptive methods: combined hormonal oral, intravaginal or transdermal contraceptives (oestrogen and progesterone), oral, injectable or implantable progesterone-based hormonal contraceptives, intrauterine device (IUD), hormone-releasing intrauterine device, bilateral tubal occlusion, vasectomised partner (as long as they are the only sexual partner of the participating patient and that the success of the intervention has been medically confirmed), or sexual abstinence (abstaining from heterosexual intercourse during the treatment period). The investigator is responsible for determining whether the patient has an appropriate contraceptive method for her participation in the study.
- Fertile men who use condoms or have had a vasectomy (as long as the success of the intervention has been medically confirmed), or who practise abstinence (abstinence from heterosexual sexual relationships during the treatment period). The investigator is responsible for determining whether the patient has an appropriate contraceptive method for their participation in the study.
- Patients who have had active cancer in the last five years.
- Patients who have received an investigational drug (including vaccines) or who have used an invasive medical device in the last 30 days prior to the start of the screening phase or who are currently participating in another clinical trial.
- Patients who have a family or professional relationship with the research team participating in the clinical study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hemorrane® Plus
Daily application of Hemorrane Plus (Hemorrane® + benzocaine) 10 mg/g rectal ointment + 30 mg/g benzocaine for 7 days.
|
Hemorrane 10 mg/g rectal ointment + 30 mg/g benzocaine
|
Active Comparator: Hemorrane®
Daily application of Hemorrane 10 mg/g rectal ointment for 7 days.
|
Hemorrane 10 mg/g rectal ointment
|
Placebo Comparator: Placebo
Daily application of placebo for 7 days.
|
Rectal ointment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of responders at T156h +30 min (day 7 hour 12 + 30min) compared to T0 (day 1 hour 0), for Hemorrane Plus and placebo; as well as the percentage of responders within 30 minutes after the application of Hemorrane Plus and Hemorrane®.
Time Frame: 7 days 12 hours 30 min
|
Responders are defined as those patients with a decrease of two or more points out of ten on the Visual Analogue Scale (VAS) of pain (assessed by the patient).
|
7 days 12 hours 30 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of responders at T156h +30 min (day 7 hour 12 + 30 min) compared to T0 (day 1 hour 0), for Hemorrane® Plus versus placebo
Time Frame: 7 days 12 hours 30 min
|
Responders are defined as those patients with a decrease of two or more points out of ten on the Visual Analogue Scale (VAS) of pain (assessed by the patient).
|
7 days 12 hours 30 min
|
Percentage of responders at T156h +30 min (day 7 hour 12 + 30min) compared to T0 (day 1 hour 0), for Hemorrane Plus and Hemorrane®
Time Frame: 7 days 12 hours 30 min
|
Responders are defined as those patients with a decrease of two or more points out of ten on the Visual Analogue Scale (VAS) of pain (assessed by the patient).
|
7 days 12 hours 30 min
|
Change in the VAS of pruritus (assessed by the patient), at the established times, compared to the baseline value (T0), for the three treatments.
Time Frame: 7 days 12 hours 30 min
|
Change in the VAS of pruritus at the established times after the application of te ointment for each of the treatments assessed by the patient using the electronic diary.
|
7 days 12 hours 30 min
|
Change in the VAS of stinging/burning (assessed by the patient), at the established times, compared to the baseline value (T0), for the three treatments.
Time Frame: 7 days 12 hours 30 min
|
Change in the VAS of pruritus at the established times after the application of te ointment for each of the treatments assessed by the patient using the electronic diary.
|
7 days 12 hours 30 min
|
Evaluation of the mean values of the bleeding episodes recorded (assessed by the investigator) at Visit 1 (Screening and baseline), and at Visit 2 (day 8+1), for the three treatments.
Time Frame: 7 days 12 hours 30 min
|
The investigator will ask about bleeding episodes before first application and after finishing the treatment (day 8+1)
|
7 days 12 hours 30 min
|
Change in the VAS of inflammation (assessed by the investigator) at Visit 2 (day 8+1), compared to baseline (T0), for the three treatments.
Time Frame: 7 days 12 hours 30 min
|
The investigator will evaluate the inflammation prior to the application of the ointment and after finishing the treatment (day 8+1)
|
7 days 12 hours 30 min
|
Change in the patient's quality of life measured with the EQ-5D-5L questionnaire, at Visit 2 (day 8+1) compared to the baseline value at Visit 1 (day 1, T0), for the three treatments
Time Frame: 7 days 12 hours 30 min
|
A quality of life questionary will be given to patients for the three treatments before and after the application of the ointment.
|
7 days 12 hours 30 min
|
Incidence of adverse events (AE)
Time Frame: 7 days 12 hours 30 min
|
Incidence of adverse events (AE) for the three treatments
|
7 days 12 hours 30 min
|
Incidence of topical allergic reactions
Time Frame: 7 days 12 hours 30 min
|
Incidence of topical allergic reactions for the three treatments
|
7 days 12 hours 30 min
|
Description of local tolerability and satisfaction
Time Frame: 7 days 12 hours 30 min
|
Description of local tolerability and satisfaction for the three treatments
|
7 days 12 hours 30 min
|
Percentage of clinically significant changes in haematology, biochemistry, and methaemoglobin analysis compared to baseline.
Time Frame: 15 +/- 2 days
|
A blood sample will be obtained before and two weeks after the start of the treatment.
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15 +/- 2 days
|
Percentage of patients withdrawn from the study for safety reasons
Time Frame: 7 days 12 hours 30 min
|
7 days 12 hours 30 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2023
Primary Completion (Actual)
January 4, 2024
Study Completion (Actual)
January 4, 2024
Study Registration Dates
First Submitted
March 15, 2023
First Submitted That Met QC Criteria
March 27, 2023
First Posted (Actual)
March 29, 2023
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 23, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEMP-0119/ES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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