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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: Completed Phase 3 study of Chronic Anal Fissures, sponsored by Ventrus Biosciences.
NCT01690221 is a Phase 3 study of Chronic Anal Fissures that has completed, run by Ventrus Biosciences. The registered enrollment target is 434 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 434 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01690221 record still lists
NCT01690221 is an interventional study that assigns participants to a tested intervention. The registered 434 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower).
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 names 20 study sites across 6 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01690221's enrollment target sits among peer trials
434 876th of 2000 higher than 1,125 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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