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

NCT01690221 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 434

Last updated 2014-01-23

No results posted yet for this study

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.

Conditions

  • Chronic Anal Fissures

Interventions

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.

Sponsors & Collaborators

  • Ventrus Biosciences, Inc

    lead INDUSTRY

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
2012-10-31
Primary Completion
2013-12-31
Completion
2014-01-31

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 NCT01690221 on ClinicalTrials.gov