Efficacy and Safety Study With Diltiazem Hydrochloride Cream to Treat Anal Fissures
- Registration Number
- NCT01690221
- Lead Sponsor
- Ventrus Biosciences, Inc
- Brief 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.
- Detailed Description
Primary Objective:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 434
- Males or females, aged ≥ 18 to ≤ 75 years.
- Subjects with evidence of a circumscribed fissure, with induration at the edges.
- 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).
- 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).
- 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.
- 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).
- 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.
- Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
- Capable of using the IVRS and able to adequately communicate comprehension of the IVRS questions to the investigator.
- Capable of and freely willing to provide written informed consent prior to participating in the study.
-
Unwilling to have visual or medical examination of the AF.
-
More than 1 AF.
-
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.
-
Unwilling to stop all other concomitant topical preparations applied in and around the anus from signing of ICF through Day 29 of the study.
-
Use of glyceryl trinitrate (GTN) ointment for 7 days (continuous or not) in the 28 days prior to signing the ICF.
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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.
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Unwilling to discontinue use of anesthetics from signing the ICF to end of study.
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Subfissure injection of botulinum toxin in the 3 months prior to signing the ICF.
-
Known sensitivity to investigational product(s) or calcium channel blockers.
-
Previous treatment with diltiazem hydrochloride cream or any other topical calcium channel blockers.
-
Active treatment with anti-viral therapies for HIV (e.g. indinavir, nelfinivir, ritonavir).
-
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
-
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.
-
History of radiation therapy to the pelvis.
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Fixed anal stenosis/fibrosis.
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Major organ transplant.
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Any clinically significant laboratory abnormalities during screening per investigator judgment.
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Body Mass Index (BMI) > 40 kg/m2
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Malignancy within 5 years prior to randomization (with the exception of treated basal cell/squamous cell carcinoma of the skin).
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Any disease or prior/planned surgery that may interfere with the subject successfully completing the study.
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Currently using narcotic(s).
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Breast-feeding females.
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Employees, family members, or students of the investigator or clinical site.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VEN 307 VEN 307 diltiazem hydrochloride 2% cream Placebo Placebo Placebo Cream
- Primary Outcome Measures
Name Time Method Change from baseline (average NRS during the last 3 days in which subject had a defecation during the 7 day screening period) in average of worst AF-related pain associated with or following defecation for Days 22-28 (Week 4). 28 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (100)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Investigative Clinical Research
🇺🇸Annapolis, Maryland, United States
Advance Medical Research Center
🇺🇸Miami, Florida, United States
Well Pharma Medical Research Corp.
🇺🇸Miami, Florida, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Kendrick Regional Medical Center
🇺🇸Indianapolis, Indiana, United States
University of TX Affiliated Hospitals
🇺🇸Houston, Texas, United States
Digestive Disease Institute, Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Morehouse School of Medicine
🇺🇸Atlanta, Georgia, United States
University of North Carolina
🇺🇸Raleigh, North Carolina, United States
Mayo Clinic - Arizona
🇺🇸Phoenix, Arizona, United States
Impact Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Duke University
🇺🇸Durham, North Carolina, United States
Westover Heights Clinic
🇺🇸Portland, Oregon, United States
University of Utah HSC
🇺🇸Salt Lake City, Utah, United States
The Crawford Clinic
🇺🇸Anniston, Alabama, United States
Surgical Association of Mobile
🇺🇸Mobile, Alabama, United States
Jefferson City Medical Group
🇺🇸Jefferson City, Missouri, United States
Desert Sun Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Cedars Sinai
🇺🇸Los Angeles, California, United States
University of Iowa Hospital and Clinics
🇺🇸Iowa City, Iowa, United States
Washington Hospital Center - MedStar Health Research Institute
🇺🇸Washington, District of Columbia, United States
Innovative Medical Research of South Florida
🇺🇸Aventura, Florida, United States
Arrowhead Regional Medical Center
🇺🇸Colton, California, United States
Akta Medika
🇺🇸Miami Beach, Florida, United States
Gastroenterology Group of Naples, PA
🇺🇸Naples, Florida, United States
UC San Diego
🇺🇸La Jolla, California, United States
Rocky Mountain Clinical Research, LLC
🇺🇸Thornton, Colorado, United States
Advanced Medical Research Center
🇺🇸Port Orange, Florida, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
NCH Medical Group
🇺🇸Arlington Heights, Illinois, United States
North Shore University Health System
🇺🇸Evanston, Illinois, United States
Alliance Research Centers
🇺🇸Laguna Hills, California, United States
South Lake Pain Institute
🇺🇸Clermont, Florida, United States
University of California - Irvine Medical Center
🇺🇸Orange, California, United States
Digestive Care Associated, A Medical Corporation
🇺🇸San Carlos, California, United States
Private Practice
🇺🇸Pembroke Pines, Florida, United States
Montgomery Women's Health Association, PC
🇺🇸Montgomery, Alabama, United States
Colorado Research Works
🇺🇸Pueblo, Colorado, United States
Gastrointestinal Specialist of Georgia
🇺🇸Marietta, Georgia, United States
Colorectal Associates of NY
🇺🇸New York, New York, United States
Gastro Center of Maryland
🇺🇸Columbia, Maryland, United States
Atlanta Center for Gastroenterology
🇺🇸Decatur, Georgia, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Research Across America
🇺🇸Dallas, Texas, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Houston Endoscopy and Research Center
🇺🇸Houston, Texas, United States
Colon and Rectal Surgery, Inc
🇺🇸Omaha, Nebraska, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
HCCA Clinical Research Solutions
🇺🇸Jackson, Tennessee, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Premier Medical Group
🇺🇸Poughkeepsie, New York, United States
Medical Research Associates of New York (New York Gastroenterology Associates, LLP)
🇺🇸New York, New York, United States
Baystate Medical Center Department of Surgery
🇺🇸Springfield, Massachusetts, United States
Manhattan Surgical Associates, LLP
🇺🇸New York, New York, United States
The Corvallis Clinic, Clinical Research Center
🇺🇸Corvallis, Oregon, United States
C&R Surgical Assoc of South Jersey
🇺🇸Voorhees, New Jersey, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Vanderbilt Univ Dept of Colon and Rectal Surgery
🇺🇸Nashville, Tennessee, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
Dayton Gastroenterology, Inc.
🇺🇸Dayton, Ohio, United States
Great Lakes Gastroenterology
🇺🇸Mentor, Ohio, United States
Drexel Univ College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Houston Digestive Disease Clinic
🇺🇸Houston, Texas, United States
Medical College of Wisconsin Department of Surgery
🇺🇸Milwaukee, Wisconsin, United States
Gastroenterology Associates of Tidewater
🇺🇸Chesapeake, Virginia, United States
ColoProctology Associates
🇺🇸Seabrook, Texas, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Institute of Pain Research
🇺🇸Oklahoma City, Oklahoma, United States
Trial Management Associates
🇺🇸Wilmington, North Carolina, United States
Pain Specialists of Charleston
🇺🇸North Charleston, South Carolina, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Connecticut Clinical Research Foundation CT Gastroenterology Institute At Bristol Hospital
🇺🇸Bristol, Connecticut, United States
Delta Research Partners
🇺🇸Monroe, Louisiana, United States
Medispect
🇺🇸Boone, North Carolina, United States
Gastrointestinal Biosciences
🇺🇸Los Angeles, California, United States
Axis Clinical Trials
🇺🇸Los Angeles, California, United States
West Coast Clinical Research
🇺🇸Tarzana, California, United States
Florida Medical Clinic, P.A.
🇺🇸Zephyrhills, Florida, United States
Georgia Health Sciences University
🇺🇸Augusta, Georgia, United States
Meritus Center For Clinical Research
🇺🇸Hagerstown, Maryland, United States
Healthcare Clinical Data, Inc.
🇺🇸North Miami, Florida, United States
Metropolitan Gastroenterology Group, Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Atlanta Gastroenterology Consultants
🇺🇸Suwanee, Georgia, United States
CRC of Jackson
🇺🇸Jackson, Mississippi, United States
Midwest Center for Clinical Research
🇺🇸Lee's Summit, Missouri, United States
Gastroenterology Group & Endoscopy Center of South NJ (GGSJ)
🇺🇸Vineland, New Jersey, United States
Life Medi-Research and Management
🇺🇸Brooklyn, New York, United States
Womack Army Medical Center
🇺🇸Ft. Bragg, North Carolina, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
West Penn Allegheny Health System
🇺🇸Monroeville, Pennsylvania, United States
Temple University Physicians, Jeanes Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Gastroenterology Associates of Orangeburg, PA
🇺🇸Orangeburg, South Carolina, United States
Research Concepts, GP LLC
🇺🇸Houston, Texas, United States
Jefferson Surgical Clinic
🇺🇸Roanoke, Virginia, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
University of South Florida, South Campus
🇺🇸Tampa, Florida, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Ochsner
🇺🇸New Orleans, Louisiana, United States
NW Gastroenterology
🇺🇸Bellevue, Washington, United States