Efficacy Study of Iferanserin to Treat Hemorrhoids

Study Overview
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Brief Summary
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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.

Official Title
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Protocol for the Study of the Effects of S-MPEC (Iferanserin) in Patients With Hemorrhoids

Conditions
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Hemorrhoids

Intervention / Treatment
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* Drug: Iferanserin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iferanserin<br>Iferanserin administration intra-anally twice daily for 14 days | Drug: Iferanserin<br>* Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days<br>* Other names: VEN309;|
| Placebo Comparator: Placebo<br>Placebo administration intra-anally twice daily for 14 days | Drug: Placebo<br>* Placebo ointment applied intra-anally twice daily for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 7 and 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days |