Study:
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
Rationale:
n/a
Purpose:
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
Recruiting:
n/a
| 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
ClinicalTrials.gov 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