Efficacy and Safety Study to Treat Subjects With Symptomatic Internal Hemorrhoids
Status:
Terminated
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
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).