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Efficacy and Safety Study to Treat Subjects With Symptomatic Internal Hemorrhoids


A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Intra-Anal Application of Iferanserin (10 mg) as a 0.5% Ointment in Subjects With Symptomatic Internal Hemorrhoids




Primary Objective: To evaluate the effect of iferanserin ointment on cessation of bleeding when administered intra-anally twice daily (BID) for 7 or 14 days in subjects with symptomatic internal hemorrhoids. Methodology: Double-Blind: Phase 3, multicenter, double-blind, randomized, parallel group, placebo-controlled part of the study. Extension: Multicenter, open-label part of the study. Study Treatment Duration: Double-Blind: 28 days (14-day treatment period and a 14-day follow-up period). Extension: 12 months (open-label part of the study in which there will be a scheduled visit every three months. Subjects who have recurrence(s) of their symptomatic internal hemorrhoids will be treated with open-label iferanserin for 7 days followed by a 21-day follow-up period). Criteria for Evaluation: Primary Endpoint: The primary endpoint is the cessation of bleeding by the end of Day 7 that persists for the remainder of the treatment period (through Day 14).

Study Status: Terminated


Condition Intervention Phase
Internal Hemorrhoids Drug: Iferanserin
Drug: Placebo
Drug: Iferanserin + Placebo
Phase 3

Verified by Ventrus Biosciences, Inc July, 2012

Sponsored by: Ventrus Biosciences, Inc
Information provided by: Ventrus Biosciences, Inc identifier: NCT01355874

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Cleveland Clinic Florida
Weston, Florida
United States

Cleveland Clinic., Principal Investigator

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