Multicenter, double-blind, randomized clinical trial to evaluate and compare the efficacy and safety of Hemorrane® Plus (Hemorrane® + benzocaine) with Hemorrane® and with placebo in patients with grade I and II hemorrhoids.

FAES FARMA SA0 sites185 target enrollmentAugust 9, 2019

Overview

No summary available.

Registry

who.int

Start Date

August 9, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Age: over 18 years.
•2\. Sex: both sexes.
•3\. Patients with grade I and II hemorrhoids.
•4\. Patients with pain assessed according to Visual Analogue Scale \= 5 points.
•5\. Patients with pruritus and burning\-sting evaluated according to Visual Analogue Scale \= 5 points.
•6\. The patient must commit to comply with the hygienic\-dietary measures established for the general management of hemorrhoids.
•7\. Urinary test of negative pregnancy in women.
•8\. Patients with adequate level for understanding the study.
•9\. The patient must have voluntarily signed the Informed Consent
•Are the trial subjects under 18? no

•1\. Subjects who have used other topical antihemorrhoids or other topical agents applicable in the same anorectal area for at least one week before the start of the study (Visit 1, day 1\), nor their use throughout the study
•2\. Hemorrhoidal surgical intervention that is scheduled from Visit 1 (day 1\) to the follow\-up visit Visit 3 (day 15\).
•3\. Severe liver disease (Child\-Pugh C).
•4\. Severe or terminal renal failure documented in the patient's medical history.
•5\. Moderate to severe cardiovascular disease documented in the patient's medical history.
•6\. History of hypersensitivity to any of the active ingredients or components of the products under investigation.
•7\. Active hemorrhoidal hemorrhage or for any other cause.
•8\. Patients with other pathologies with symptoms similar to hemorrhoidal disease, and patients with more serious pathologies that may cause rectorrhagia.
•9\. Patients with bacterial, viral and / or fungal infections of the perianal region. 10\. Have the diagnostic test for pancreatic puncture with bentiromide scheduled from Visit 1 (day 1\) to the follow\-up visit Visit 3 (day 15\).
•11\. Be on treatment with any of the prohibited concomitant medications (sulfonamides, cholinesterase inhibitors, local ester anesthetics) for at least one week before the start of the study (Visit 1, day 1\), or its use throughout the study.