Back to resultsEfficacy Study of Iferanserin to Treat Hemorrhoids
Primary Purpose
Hemorrhoids
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Iferanserin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoids
Eligibility 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.
Sites / Locations
- Prof. Alexander Herold, MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Iferanserin
Placebo
Arm Description
Iferanserin administration intra-anally twice daily for 14 days
Placebo administration intra-anally twice daily for 14 days
Outcomes
Primary Outcome Measures
Assessment of hemorrhoid bleeding
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.
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.
Full Information
NCT ID
NCT01483833
First Posted
November 22, 2011
Last Updated
August 19, 2013
Sponsor
Ventrus Biosciences, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01483833
Brief Title
Efficacy Study of Iferanserin to Treat Hemorrhoids
Official Title
Protocol for the Study of the Effects of S-MPEC (Iferanserin) in Patients With Hemorrhoids
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
August 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ventrus Biosciences, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iferanserin
Arm Type
Active Comparator
Arm Description
Iferanserin administration intra-anally twice daily for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administration intra-anally twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Iferanserin
Other Intervention Name(s)
VEN309
Intervention Description
Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo ointment applied intra-anally twice daily for 14 days
Primary Outcome Measure Information:
Title
Assessment of hemorrhoid bleeding
Description
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.
Time Frame
Day 7 and 14
Secondary Outcome Measure Information:
Title
Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids.
Description
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.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Prof. Alexander Herold, MD
City
Mannheim
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22244049
Citation
Herold A, Dietrich J, Aitchison R. Intra-anal Iferanserin 10 mg BID for hemorrhoid disease: a prospective, randomized, double-blind, placebo-controlled trial. Clin Ther. 2012 Feb;34(2):329-40. doi: 10.1016/j.clinthera.2011.12.012. Epub 2012 Jan 11.
Results Reference
derived
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Efficacy Study of Iferanserin to Treat Hemorrhoids
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