NCT01690221

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 434 (actual)
• Sponsor: Ventrus Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Chronic Anal Fissures

Interventions

Type	Name	Description
DRUG	VEN 307	VEN307 applied three times a day, in and around the anus, for 28 days.
DRUG	Placebo	Placebo cream applied three times a day, in and around the anus, for 28 days.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2012-09-21
• Last updated: 2014-01-23

Locations

103 sites across 1 country: United States