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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: August 19, 2013
Last verified: November 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on November 24, 2014