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

Tracking Information
First Received Date ^ICMJE	November 22, 2011
Last Updated Date	November 29, 2011
Start Date ^ICMJE	September 2001
Primary Completion Date	August 2002 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 29, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01483833 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 29, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy Study of Iferanserin to Treat Hemorrhoids
Official Title ^ICMJE	Protocol for the Study of the Effects of S-MPEC (Iferanserin) in Patients With Hemorrhoids
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Hemorrhoids
Intervention ^ICMJE	Drug: Iferanserin Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days Other Name: VEN309 Drug: Placebo Placebo ointment applied intra-anally twice daily for 14 days
Study Arm (s)	Active Comparator: Iferanserin Iferanserin administration intra-anally twice daily for 14 days Intervention: Drug: Iferanserin Placebo Comparator: Placebo Placebo administration intra-anally twice daily for 14 days Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	121
Completion Date	August 2002
Primary Completion Date	August 2002 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01483833
Other Study ID Numbers ^ICMJE	VEN309-SMPEC-001
Has Data Monitoring Committee	No
Responsible Party	Ventrus Biosciences, Inc
Study Sponsor ^ICMJE	Ventrus Biosciences, Inc
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Ventrus Biosciences, Inc
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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