Efficacy Study of Iferanserin to Treat Hemorrhoids

Ventrus Biosciences, Inc121 enrolled

Overview

To evaluate the safety and efficacy of topical 0.5% S-MPEC cream vs. placebo cream (applied twice daily for 14 days) in the treatment of Grade I - III hemorrhoids.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

121

Conditions

Hemorrhoids

Interventions

IferanserinDRUG

Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days

PlaceboDRUG

Placebo ointment applied intra-anally twice daily for 14 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or older * Diagnosis of grade I - III hemorrhoids with bleeding episodes of at least every other day during the last two weeks before enrollment in the study. * Patients signing the Informed Consent form. Exclusion Criteria: * Patients with protruding or irreducible hemorrhoids (grade IV). * Patients with anal fistulas, periproctitis or hemorrhagic diathesis * Patients with current history of Type I or Type II diabetes mellitus. * Patients with severe hepatic, renal or cardiovascular disorders. * Patients with any type of infectious disease. * Patients who have been involved with another experimental drug trial within the past 30 days. * Patients presently diagnosed with cancer. * Patients who have known alcohol and drug abuse. * Patients who require the use of suppositories. * Patients with blood or urine laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator.

Locations (1)

Prof. Alexander Herold, MD

Mannheim, Germany

Outcomes

Primary Outcomes

Assessment of hemorrhoid bleeding

Change from pre-treatment in patient assessment of hemorrhoid bleeding (10-point scale: 1=Not at all, 10=Extremely) at the end of one- and two-weeks of treatment are the primary efficacy endpoints for the study.

Time frame: Day 7 and 14

Secondary Outcomes

Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids.

Change from pre-treatment in patient assessment of bleeding on other treatment days, change from pre-treatment in hemorrhoid size, change from pre-treatment in patient assessment of other hemorrhoid symptoms/conditions on all treatment days, and physician evaluation of hemorrhoids at the end of treatment.

Time frame: 14 days

Data from ClinicalTrials.gov

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