Efficacy Study of Iferanserin to Treat Hemorrhoids

This study has been completed.
Information provided by (Responsible Party):
Ventrus Biosciences, Inc
ClinicalTrials.gov Identifier:
First received: November 22, 2011
Last updated: August 19, 2013
Last verified: November 2011
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
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:

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


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

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

Prof. Alexander Herold, MD
Mannheim, Germany
Sponsors and Collaborators
Ventrus Biosciences, Inc
  More Information

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: August 19, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 25, 2016