Efficacy Study of Iferanserin to Treat Hemorrhoids

August 19, 2013 updated by: Ventrus Biosciences, Inc

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany
        • Prof. Alexander Herold, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Iferanserin
Iferanserin administration intra-anally twice daily for 14 days
Drug: Iferanserin
Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days
Other Names:
  • VEN309
Placebo Comparator: Placebo
Placebo administration intra-anally twice daily for 14 days
Drug: Placebo
Placebo ointment applied intra-anally twice daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of hemorrhoid bleeding
Time Frame: 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.
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.
Time Frame: 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.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ventrus Biosciences, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

August 1, 2002

Study Completion (Actual)

August 1, 2002

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

December 1, 2011

Study Record Updates

Last Update Posted (Estimate)

August 21, 2013

Last Update Submitted That Met QC Criteria

August 19, 2013

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEN309-SMPEC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemorrhoids

Clinical Trials on Iferanserin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe