Haemorrhoids Without ComplicationPhase 3NCT05788497
Efficacy and Safety of Hemorrane Plus Versus Hemorrane and Versus Placebo in Patients With Uncomplicated Haemorrhoids
A Phase 3 study testing Hemorrane plus and Hemorrane in people with Haemorrhoids Without Complication, run by Faes Farma, S.A. at 13 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemorrhoids Without Complication
- What is being tested?
- Hemorrane plus and Hemorrane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 13 sitesSpain
- Study dates
- 30 Mar 2023to 4 Jan 2024
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
CS A Estrada
A Estrada, Pontevedra, 36680
CS Ávila Estación
Ávila, 5001
CAP Can Bou
Castelldefels, Barcelona, 08860
CAP Corbera de Llobregat
Corbera de Llobregat, Barcelona, 08757
CAPSBE Les Corts
L'Hospitalet de Llobregat, Barcelona, 08028
CS Dr. Mendiguchia Carriche
Leganés, Madrid, 28914
CS Montesa
Madrid, 28006
CS Goya
Madrid, 28009
CS Fuencarral
Madrid, 28034
CS General Fanjul
Madrid, 28044
CS Las Fronteras
Torrejón de Ardoz, Madrid, 28850
CS Trinitat
Valencia, Valencia, 46010
CS Trafalgar
Valencia, Valencia, 46023
About this study
Official title: 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.
- Conditions
- Haemorrhoids Without Complication
- Being tested
- Hemorrane plus, Hemorrane, Placebo
- Keywords
- Haemorrhoids, Haemorrhoids without complication
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemorrane plusDrug
Hemorrane 10 mg/g rectal ointment + 30 mg/g benzocaine
HemorraneDrug
Hemorrane 10 mg/g rectal ointment
PlaceboDrug
Rectal ointment
| Study group | Role | What they receive |
|---|---|---|
| Hemorrane® Plus | Experimental | Daily application of Hemorrane Plus (Hemorrane® + benzocaine) 10 mg/g rectal ointment + 30 mg/g benzocaine for 7 days. Receives: Drug: Hemorrane plus |
| Hemorrane® | Active comparator | Daily application of Hemorrane 10 mg/g rectal ointment for 7 days. Receives: Drug: Hemorrane |
| Placebo | Placebo comparator | Daily application of placebo for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®.
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).
Measured: 7 days 12 hours 30 min
Secondary outcomes (12)
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
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).
Measured: 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®
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).
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
The investigator will ask about bleeding episodes before first application and after finishing the treatment (day 8+1)
Measured: 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.
The investigator will evaluate the inflammation prior to the application of the ointment and after finishing the treatment (day 8+1)
Measured: 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
A quality of life questionary will be given to patients for the three treatments before and after the application of the ointment.
Measured: 7 days 12 hours 30 min
Incidence of adverse events (AE)
Incidence of adverse events (AE) for the three treatments
Measured: 7 days 12 hours 30 min
Incidence of topical allergic reactions
Incidence of topical allergic reactions for the three treatments
Measured: 7 days 12 hours 30 min
Description of local tolerability and satisfaction
Description of local tolerability and satisfaction for the three treatments
Measured: 7 days 12 hours 30 min
Percentage of clinically significant changes in haematology, biochemistry, and methaemoglobin analysis compared to baseline.
A blood sample will be obtained before and two weeks after the start of the treatment.
Measured: 15 +/- 2 days
Percentage of patients withdrawn from the study for safety reasons
Measured: 7 days 12 hours 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start30 Mar 2023
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Why it stopped: Recruitment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemorrhoids Without ComplicationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faes Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dynamic Science S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788497
- Sponsor's protocol ID
- HEMP-0119/ES
- Status last verified
- Feb 2024
- First submitted
- 15 Mar 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05788497
- Acronym / sponsor ID
- HEMP-0119/ES
- Conditions
- Haemorrhoids Without Complication
- Keywords
- Haemorrhoids, Haemorrhoids without complication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment failure
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Faes Farma, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Dynamic Science S.L.
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 29 Mar 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemorrane® Plus | Experimental | Drug: Hemorrane plusDaily application of Hemorrane Plus (Hemorrane® + benzocaine) 10 mg/g rectal ointment + 30 mg/g benzocaine for 7 days. |
| Hemorrane® | Active comparator | Drug: HemorraneDaily application of Hemorrane 10 mg/g rectal ointment for 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboDaily application of placebo for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
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 |
|---|---|---|
| Hemorrane plusHemorrane 10 mg/g rectal ointment + 30 mg/g benzocaine | Drug | Hemorrane® Plus |
| HemorraneHemorrane 10 mg/g rectal ointment | Drug | Hemorrane® |
| PlaceboRectal ointment | Drug | Placebo |
Primary outcome
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).
12 secondary outcomes
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
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
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 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
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
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
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
Incidence of adverse events (AE)
Time frame: 7 days 12 hours 30 min
Incidence of topical allergic reactions
Time frame: 7 days 12 hours 30 min
Description of local tolerability and satisfaction
Time frame: 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
Percentage of patients withdrawn from the study for safety reasons
Time frame: 7 days 12 hours 30 min
Results and safety
The study was stopped early (reason given: Recruitment failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hemorrane plus and Hemorrane in people with Haemorrhoids Without Complication, run by Faes Farma, S.A. at 13 sites in Spain.
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 8 inclusion and 19 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: stopped early, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment failure). Results are not available in the source record.
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?
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). 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 28 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.