Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2001-09-30
2002-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Iferanserin
Iferanserin administration intra-anally twice daily for 14 days
Iferanserin
Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days
Placebo
Placebo administration intra-anally twice daily for 14 days
Placebo
Placebo ointment applied intra-anally twice daily for 14 days
Interventions
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Iferanserin
Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days
Placebo
Placebo ointment applied intra-anally twice daily for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Ventrus Biosciences, Inc
INDUSTRY
Responsible Party
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Locations
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Prof. Alexander Herold, MD
Mannheim, , Germany
Countries
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References
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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.
Other Identifiers
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VEN309-SMPEC-001
Identifier Type: -
Identifier Source: org_study_id