Efficacy Study of Iferanserin to Treat Hemorrhoids

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ventrus Biosciences, Inc

ClinicalTrials.gov Identifier:

NCT01483833

First received: November 22, 2011

Last updated: November 29, 2011

Last verified: November 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
Hemorrhoids	Drug: Iferanserin Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Protocol for the Study of the Effects of S-MPEC (Iferanserin) in Patients With Hemorrhoids

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids

U.S. FDA Resources

Further study details as provided by Ventrus Biosciences, Inc:

Primary Outcome Measures:

Assessment of hemorrhoid bleeding [ Time Frame: Day 7 and 14 ] [ Designated as safety issue: No ]
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:

Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
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.

Enrollment:	121
Study Start Date:	September 2001
Study Completion Date:	August 2002
Primary Completion Date:	August 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483833

Locations

Germany
Prof. Alexander Herold, MD
Mannheim, Germany

Sponsors and Collaborators

Ventrus Biosciences, Inc

More Information

No publications provided

Responsible Party:	Ventrus Biosciences, Inc
ClinicalTrials.gov Identifier:	NCT01483833 History of Changes
Other Study ID Numbers:	VEN309-SMPEC-001
Study First Received:	November 22, 2011
Last Updated:	November 29, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases

Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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