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Calcium Channel Blocker

Diltiazem Hydrochloride for Anal fissures

Phase 1
Waitlist Available
Research Sponsored by Ventrus Biosciences, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after enrollment begins
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

The study is a single-center, open-label, safety and pharmacokinetic study in12 adult subjects with Anal Fissures. Subjects will be screened to determine eligibility within 7 days of treatment. There will be three parts to the study and all subjects will participate in each part.

Eligible Conditions
  • Anal fissures

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after enrollment begins
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after enrollment begins for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Single and multiple dose Pharmacokinetic parameters
Secondary study objectives
Safety as determined by nature, severity and relationship of adverse events, clinical labs, physical exam findings, vital signs and Electrocardiogram

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diltiazem HydrochlorideExperimental Treatment1 Intervention
Topical cream and oral pill

Find a Location

Who is running the clinical trial?

Ventrus Biosciences, IncLead Sponsor
6 Previous Clinical Trials
1,212 Total Patients Enrolled
~1 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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