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NCT01690221 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Chronic Anal Fissures, sponsored by Ventrus Biosciences.

Completed
Registry status
Phase 3
Development phase
434
Enrollment target
20
Study locations

NCT01690221 is a Phase 3 study of Chronic Anal Fissures that has completed, run by Ventrus Biosciences. The registered enrollment target is 434 participants. The trial reports 20 study locations across 6 states.

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The verdict

NCT01690221, a Phase 3 study of Chronic Anal Fissures, has completed, sponsored by Ventrus Biosciences.

COMPLETED
Registry status
Phase 3
Development phase
434 participants
Enrollment target
20
Study locations

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 Studied

Interventions

  • DRUG Placebo
  • DRUG VEN 307

Study Locations (20)

California

  • Arrowhead Regional Medical Center - Colton
  • UC San Diego - La Jolla
  • Alliance Research Centers - Laguna Hills
  • Axis Clinical Trials - Los Angeles
  • Cedars Sinai - Los Angeles
  • Gastrointestinal Biosciences - Los Angeles
  • University of California - Irvine Medical Center - Orange
  • Digestive Care Associated, A Medical Corporation - San Carlos
  • West Coast Clinical Research - Tarzana

Alabama

  • The Crawford Clinic - Anniston
  • Surgical Association of Mobile - Mobile
  • University of South Alabama - Mobile
  • Montgomery Women's Health Association, PC - Montgomery

Colorado

  • Rocky Mountain Clinical Research, LLC - Denver
  • Colorado Research Works - Pueblo
  • Rocky Mountain Clinical Research, LLC - Thornton

Arizona

  • Mayo Clinic - Arizona - Phoenix
  • Desert Sun Clinical Research, LLC - Tucson

Connecticut

  • Connecticut Clinical Research Foundation CT Gastroenterology Institute At Bristol Hospital - Bristol

District of Columbia

  • Washington Hospital Center - MedStar Health Research Institute - Washington D.C.

Trial Details

FieldValue
Enrollment Target 434 participants
Start Date 2012-10
Est. Completion 2014-01
Phase Phase 3

Sponsor

Ventrus Biosciences

3 total trials

What the Registry Record Tells You About NCT01690221

The ClinicalTrials.gov registry entry for NCT01690221 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 434 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ventrus Biosciences, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Anal Fissures appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01690221 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Alabama, Colorado.

Frequently Asked Questions

What is clinical trial NCT01690221 about?

NCT01690221 is a clinical study titled "Efficacy and Safety Study With Diltiazem Hydrochloride Cream to Treat Anal Fissures". 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.

What is the current status of trial NCT01690221?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 434 participants. The study started on 2012-10. Estimated completion is 2014-01.

What conditions does trial NCT01690221 study?

This clinical trial studies the following conditions: Chronic Anal Fissures.

What interventions are being tested in trial NCT01690221?

The interventions under investigation include: Placebo (DRUG), VEN 307 (DRUG).

Who is sponsoring clinical trial NCT01690221?

This trial is sponsored by Ventrus Biosciences, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01690221 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.