Efficacy Study of Iferanserin to Treat Hemorrhoids

Phase 2

Completed

• Conditions: Hemorrhoids
• Interventions: Drug: Placebo; Drug: Iferanserin

• Registration Number: NCT01483833
• Lead Sponsor: Ventrus Biosciences, Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2002-08
• Study Completion: 2002-08
• Status Verified: 2011-11
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-12-01
• Last Update Submitted: 2013-08-19
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administration intra-anally twice daily for 14 days
Iferanserin	Iferanserin	Iferanserin administration intra-anally twice daily for 14 days

Primary Outcome Measures

Name	Time	Method
Assessment of hemorrhoid bleeding	Day 7 and 14	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids.	14 days	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.

Trial Locations

Locations (1)

Prof. Alexander Herold, MD; 🇩🇪 Mannheim, Germany