Efficacy and Safety Study With Diltiazem Hydrochloride Cream to Treat Anal Fissures
NCT ID: NCT01690221
Last Updated: 2014-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
434 participants
INTERVENTIONAL
2012-10-31
2014-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride
NCT01816191
Diltiazem Hydrochloride Cream for Anal Fissure
NCT01217515
Diltiazem Ointment With Lidocaine vs. Nifedipine Ointment With Lidocaine Ointment for Treatment of Chronic Anal Fissure
NCT04887818
The Efficacy of Botulinum Toxin Alone Versus Combined Botulinum Toxin and Topical Diltiazem in Chronic Anal Fissure
NCT05797220
A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures
NCT00522041
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
VEN 307
diltiazem hydrochloride 2% cream
VEN 307
VEN307 applied three times a day, in and around the anus, for 28 days.
Placebo
Placebo Cream
Placebo
Placebo cream applied three times a day, in and around the anus, for 28 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VEN 307
VEN307 applied three times a day, in and around the anus, for 28 days.
Placebo
Placebo cream applied three times a day, in and around the anus, for 28 days.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subjects with evidence of a circumscribed fissure, with induration at the edges.
3. Subjects with AF-related pain associated with or following defecation occurring at least 2 times a week for at least 28 days prior to signing the informed consent form (ICF).
4. AF-related pain associated with or following defecation of at least 5 on an 11-point numerical rating score scale (NRS) at the last defecation prior to signing the ICF (0 being no pain; 10 being the worst possible pain).
5. Average AF-related pain associated with or following defecation of at least 5 on an 11-point NRS during the last 3 days in which subject had a defecation during the 7 days prior to randomization.
6. Any female of non-childbearing potential, including any female who: a) has had a hysterectomy, b) has had a bilateral oophorectomy, c) has had a bilateral tubal ligation or d) is post menopausal (demonstration of total cessation of menses for ≥ 1 year from the date of screening visit).
7. Females of child bearing potential who agree to use at least one form of contraception (may be a barrier method), during the full duration of the study.
8. Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
9. Capable of using the IVRS and able to adequately communicate comprehension of the IVRS questions to the investigator.
10. Capable of and freely willing to provide written informed consent prior to participating in the study.
Exclusion Criteria
2. More than 1 AF.
3. Subjects with AF associated with or caused by other conditions, including but not limited to: drug-induced, trauma, HIV infection, fistula-in-ano, inflammatory bowel disease, perianal sepsis or malignancy.
4. Unwilling to stop all other concomitant topical preparations applied in and around the anus from signing of ICF through Day 29 of the study.
5. Use of glyceryl trinitrate (GTN) ointment for 7 days (continuous or not) in the 28 days prior to signing the ICF.
6. Unwilling to discontinue use of sitz baths for up to 4 hours after each application of investigational product from signing of ICF to end of study.
7. Unwilling to discontinue use of anesthetics from signing the ICF to end of study.
8. Subfissure injection of botulinum toxin in the 3 months prior to signing the ICF.
9. Known sensitivity to investigational product(s) or calcium channel blockers.
10. Previous treatment with diltiazem hydrochloride cream or any other topical calcium channel blockers.
11. Active treatment with anti-viral therapies for HIV (e.g. indinavir, nelfinivir, ritonavir).
12. Treatment with any of the following medications within 14 days prior to signing the ICF:
* Amitriptyline
* Benzodiazepines
* β-adrenoceptor antagonists (Beta-Blockers)
* Buspirone
* Calcium channel blockers
* Carbamazepine
* Cimetidine
* Cyclosporin
* Digoxin
* Investigational agents
* Lovastatin
* Opioids
* Pregabalin
* Quinidine
* Rifampin
13. Following concomitant disease state:
* Sick sinus syndrome except in the presence of a functioning ventricular pacemaker.
* Second-or third-degree AV block except in the presence of a functioning ventricular pacemaker.
* Hypotension (less than 90 mm Hg systolic).
* Acute myocardial infarction and pulmonary congestion documented by x-ray.
* History of bipolar disorder, psychosis, schizophrenia, mania, suicide attempt or suicidal ideation, or any other significant psychiatric illness (with the exception of intermittent anxiety) per investigator judgment.
* History of clinically significant renal disease per investigator judgment.
* History of clinically significant Alzheimer's or Parkinson's disease per investigator judgment.
* History of clinically significant hepatic disease per investigator judgment.
* Current infection treated with a macrolide antibiotic.
* Clinical evidence or history of fecal incontinence.
* Clinical evidence or history of anal fistula.
* Clinical evidence or history of anal abscess.
* History of inflammatory bowel disease (e.g. Crohn's disease, Ulcerative Colitis).
* History of any prior anal or rectal surgery including but not limited to: lateral sphincterotomy and anal stretch (with the exception of hemorrhoidal banding and laser surgery).
* Grade 4 hemorrhoids.
* Chronic constipation.
14. History of radiation therapy to the pelvis.
15. Fixed anal stenosis/fibrosis.
16. Major organ transplant.
17. Any clinically significant laboratory abnormalities during screening per investigator judgment.
18. Body Mass Index (BMI) \> 40 kg/m2
19. Malignancy within 5 years prior to randomization (with the exception of treated basal cell/squamous cell carcinoma of the skin).
20. Any disease or prior/planned surgery that may interfere with the subject successfully completing the study.
21. Currently using narcotic(s).
22. Breast-feeding females.
23. Employees, family members, or students of the investigator or clinical site.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ventrus Biosciences, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Crawford Clinic
Anniston, Alabama, United States
Surgical Association of Mobile
Mobile, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
Montgomery Women's Health Association, PC
Montgomery, Alabama, United States
Mayo Clinic - Arizona
Phoenix, Arizona, United States
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States
Arrowhead Regional Medical Center
Colton, California, United States
UC San Diego
La Jolla, California, United States
Alliance Research Centers
Laguna Hills, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Cedars Sinai
Los Angeles, California, United States
Gastrointestinal Biosciences
Los Angeles, California, United States
University of California - Irvine Medical Center
Orange, California, United States
Digestive Care Associated, A Medical Corporation
San Carlos, California, United States
West Coast Clinical Research
Tarzana, California, United States
Rocky Mountain Clinical Research, LLC
Denver, Colorado, United States
Colorado Research Works
Pueblo, Colorado, United States
Rocky Mountain Clinical Research, LLC
Thornton, Colorado, United States
Connecticut Clinical Research Foundation CT Gastroenterology Institute At Bristol Hospital
Bristol, Connecticut, United States
Washington Hospital Center - MedStar Health Research Institute
Washington D.C., District of Columbia, United States
Innovative Medical Research of South Florida
Aventura, Florida, United States
South Lake Pain Institute
Clermont, Florida, United States
Private Practice
Hollywood, Florida, United States
Advance Medical Research Center
Miami, Florida, United States
Well Pharma Medical Research Corp.
Miami, Florida, United States
Akta Medika
Miami Beach, Florida, United States
Gastroenterology Group of Naples, PA
Naples, Florida, United States
Healthcare Clinical Data, Inc.
North Miami, Florida, United States
Private Practice
Pembroke Pines, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
University of South Florida, South Campus
Tampa, Florida, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Georgia Health Sciences University
Augusta, Georgia, United States
Atlanta Center for Gastroenterology
Decatur, Georgia, United States
Gastrointestinal Specialist of Georgia
Marietta, Georgia, United States
Atlanta Gastroenterology Consultants
Suwanee, Georgia, United States
NCH Medical Group
Arlington Heights, Illinois, United States
North Shore University Health System
Evanston, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Kendrick Regional Medical Center
Indianapolis, Indiana, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Louisville
Louisville, Kentucky, United States
Delta Research Partners
Monroe, Louisiana, United States
Ochsner
New Orleans, Louisiana, United States
Investigative Clinical Research
Annapolis, Maryland, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Metropolitan Gastroenterology Group, Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Gastro Center of Maryland
Columbia, Maryland, United States
Meritus Center For Clinical Research
Hagerstown, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Baystate Medical Center Department of Surgery
Springfield, Massachusetts, United States
Center for Digestive Health
Troy, Michigan, United States
CRC of Jackson
Jackson, Mississippi, United States
Jefferson City Medical Group
Jefferson City, Missouri, United States
Midwest Center for Clinical Research
Lee's Summit, Missouri, United States
Colon and Rectal Surgery, Inc
Omaha, Nebraska, United States
Impact Clinical Trials
Las Vegas, Nevada, United States
Gastroenterology Group & Endoscopy Center of South NJ (GGSJ)
Vineland, New Jersey, United States
C&R Surgical Assoc of South Jersey
Voorhees Township, New Jersey, United States
Life Medi-Research and Management
Brooklyn, New York, United States
HCCA Clinical Research Solutions
New York, New York, United States
Manhattan Surgical Associates, LLP
New York, New York, United States
Colorectal Associates of NY
New York, New York, United States
Medical Research Associates of New York (New York Gastroenterology Associates, LLP)
New York, New York, United States
Premier Medical Group
Poughkeepsie, New York, United States
Medispect
Boone, North Carolina, United States
Duke University
Durham, North Carolina, United States
Womack Army Medical Center
Fort Bragg, North Carolina, United States
University of North Carolina
Raleigh, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Trial Management Associates
Wilmington, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Dayton Gastroenterology, Inc.
Dayton, Ohio, United States
Great Lakes Gastroenterology
Mentor, Ohio, United States
Institute of Pain Research
Oklahoma City, Oklahoma, United States
Bend Memorial Clinic
Bend, Oregon, United States
The Corvallis Clinic, Clinical Research Center
Corvallis, Oregon, United States
Westover Heights Clinic
Portland, Oregon, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
West Penn Allegheny Health System
Monroeville, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Drexel Univ College of Medicine
Philadelphia, Pennsylvania, United States
Temple University Physicians, Jeanes Hospital
Philadelphia, Pennsylvania, United States
Pain Specialists of Charleston
North Charleston, South Carolina, United States
Gastroenterology Associates of Orangeburg, PA
Orangeburg, South Carolina, United States
HCCA Clinical Research Solutions
Jackson, Tennessee, United States
Vanderbilt Univ Dept of Colon and Rectal Surgery
Nashville, Tennessee, United States
Research Across America
Dallas, Texas, United States
Research Concepts, GP LLC
Houston, Texas, United States
University of TX Affiliated Hospitals
Houston, Texas, United States
Houston Endoscopy and Research Center
Houston, Texas, United States
Houston Digestive Disease Clinic
Houston, Texas, United States
ColoProctology Associates
Seabrook, Texas, United States
University of Utah HSC
Salt Lake City, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Jefferson Surgical Clinic
Roanoke, Virginia, United States
NW Gastroenterology
Bellevue, Washington, United States
Digestive Disease Institute, Virginia Mason Medical Center
Seattle, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Medical College of Wisconsin Department of Surgery
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VEN307-AF-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.