Clinical Trial: Efficacy and Safety Study With Diltiazem Hydrochloride Cream to Treat Anal Fissures

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Topical Diltiazem Hydrochloride 2% Cream in Subjects With Anal Fissure

Brief Summary: The purpose of this study is to determine if the study drug, VEN307 (diltiazem hydrochloride cream) is safe and to see if it will help with treatment of pain associated with anal fissures.

Detailed Summary:

Primary Objective:

To evaluate the efficacy of diltiazem hydrochloride cream on reduction of worst anal fissure (AF)-related pain associated with or following defecation when administered three times a day (TID) for 28 days.

Sponsor: Ventrus Biosciences, Inc

Current Primary Outcome: Change from baseline (average NRS during the last 3 days in which subject had a defecation during the 7 day screening period) in average of worst AF-related pain associated with or following defecation for Days 22-28 (Week 4). [ Time Frame: 28 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ventrus Biosciences, Inc

Dates:
Date Received: September 17, 2012
Date Started: October 2012
Date Completion:
Last Updated: January 22, 2014
Last Verified: January 2014