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Efficacy and Safety Study to Treat Subjects With Symptomatic Internal Hemorrhoids

NCT01355874 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2014-01-28

No results posted yet for this study

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).

Conditions

  • Internal Hemorrhoids

Interventions

DRUG

Iferanserin

0.5% iferanserin ointment (containing 10 mg of iferanserin) BID for 14 days during double blind.

DRUG

Placebo

Placebo ointment BID for 14 days during double blind.

DRUG

Iferanserin + Placebo

0.5% iferanserin ointment (containing 10 mg of iferanserin) BID for 7 days followed by placebo ointment BID for 7 days during the double blind.

Sponsors & Collaborators

  • Ventrus Biosciences, Inc

    lead INDUSTRY

Principal Investigators

  • Cleveland Clinic · Cleveland Clinic Weston, FL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01355874 on ClinicalTrials.gov