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

Faes Farma, S.A.13 sites in 1 country21 target enrollmentMarch 30, 2023

ConditionsHaemorrhoids Without Complication

InterventionsHemorrane plus Hemorrane Placebo

DrugsHemorrane plus Hemorrane Placebo

Overview

Phase: Phase 3
Intervention: Hemorrane plus
Conditions: Haemorrhoids Without Complication
Sponsor: Faes Farma, S.A.
Enrollment: 21
Locations: 13
Primary Endpoint: 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®.
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 30, 2023

End Date

January 4, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Faes Farma, S.A.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Hemorrane® Plus

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

Intervention: Hemorrane plus

Hemorrane®

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

Intervention: Hemorrane

Placebo

Daily application of placebo for 7 days.

Intervention: Placebo

Outcomes

Primary Outcomes

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).

Secondary Outcomes

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)
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 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)
Incidence of topical allergic reactions(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)
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)
Description of local tolerability and satisfaction(7 days 12 hours 30 min)
Percentage of patients withdrawn from the study for safety reasons(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.(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(7 days 12 hours 30 min)
Incidence of adverse events (AE)(7 days 12 hours 30 min)
Percentage of clinically significant changes in haematology, biochemistry, and methaemoglobin analysis compared to baseline.(15 +/- 2 days)