Efficacy and Safety Study to Treat Subjects With Symptomatic Internal Hemorrhoids
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).
Timeline
- Start
- 2011-07
- Primary completion
- 2012-06
- Completion
- 2012-06
Outcome
Missed primary endpoint
Stopped: “The primary endpoint was not met on the double blind data”
release “clinical trial of iferanserin (VEN 309) in patients with hemorrhoidal disease did not meet its endpoints.” assemblybio.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iferanserin | Small molecule | 10 mg | Other |