Efficacy and Safety of Hemorrane Plus Versus Hemorrane and Versus Placebo in Patients With Uncomplicated Haemorrhoids

NCT05788497 | Terminated Phase 3

• 1 other identifier: HEMP-0119/ES
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Haemorrhoids Without Complication

Keywords

Haemorrhoids; Haemorrhoids without complication

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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®

  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.

  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.

  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.

  7 days 12 hours 30 min

Study Arms (3)

Hemorrane® Plus

EXPERIMENTAL

Daily application of Hemorrane Plus (Hemorrane® + benzocaine) 10 mg/g rectal ointment + 30 mg/g benzocaine for 7 days.

Drug: Hemorrane plus

Hemorrane®

ACTIVE COMPARATOR

Daily application of Hemorrane 10 mg/g rectal ointment for 7 days.

Drug: Hemorrane

Placebo

PLACEBO COMPARATOR

Daily application of placebo for 7 days.

Drug: Placebo

Interventions

Hemorrane plus DRUG

Hemorrane 10 mg/g rectal ointment + 30 mg/g benzocaine

Hemorrane® Plus

Hemorrane DRUG

Hemorrane 10 mg/g rectal ointment

Hemorrane®

Placebo DRUG

Rectal ointment

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faes Farma, S.A.: lead
• Dynamic Science S.L.: collaborator

Study Sites (13)

CAP Can Bou

Castelldefels, Barcelona, 08860, Spain

Location

CAP Corbera de Llobregat

Corbera de Llobregat, Barcelona, 08757, Spain

Location

CAPSBE Les Corts

L'Hospitalet de Llobregat, Barcelona, 08028, Spain

Location

CS Dr. Mendiguchia Carriche

Leganés, Madrid, 28914, Spain

Location

CS Las Fronteras

Torrejón de Ardoz, Madrid, 28850, Spain

Location

CS A Estrada

A Estrada, Pontevedra, 36680, Spain

Location

CS Trinitat

Valencia, Valencia, 46010, Spain

Location

CS Trafalgar

Valencia, Valencia, 46023, Spain

Location

CS Ávila Estación

Ávila, 5001, Spain

Location

CS Montesa

Madrid, 28006, Spain

Location

CS Goya

Madrid, 28009, Spain

Location

CS Fuencarral

Madrid, 28034, Spain

Location

CS General Fanjul

Madrid, 28044, Spain

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: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 29, 2023
• Study Start: March 30, 2023
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

ES (13)