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Chronic Anal FissuresPhase 3NCT01690221

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

A Phase 3 study testing VEN 307 in people with Chronic Anal Fissures, run by Ventrus Biosciences, Inc at 103 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Anal Fissures
What is being tested?
VEN 307
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
434 participants
Where
103 sitesUnited States
Study dates
Oct 2012to Jan 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
  • 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.
  • 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.
  • Fixed anal stenosis/fibrosis.
  • Major organ transplant.
  • Any clinically significant laboratory abnormalities during screening per investigator judgment.
  • Body Mass Index (BMI) > 40 kg/m2
  • Malignancy within 5 years prior to randomization (with the exception of treated basal cell/squamous cell carcinoma of the skin).
  • Any disease or prior/planned surgery that may interfere with the subject successfully completing the study.
  • Currently using narcotic(s).
  • Breast-feeding females.
  • Employees, family members, or students of the investigator or clinical site.

Trial locations and contacts

103 sites in 1 country.

103 sites in 1 country

United States103 sites

  • Investigative Clinical Research

    Annapolis, Maryland, 21401

  • The Crawford Clinic

    Anniston, Alabama, 36207

  • NCH Medical Group

    Arlington Heights, Illinois, 60004

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

  • Georgia Health Sciences University

    Augusta, Georgia, 30912

  • Innovative Medical Research of South Florida

    Aventura, Florida, 33160

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • NW Gastroenterology

    Bellevue, Washington, 98004

  • Bend Memorial Clinic

    Bend, Oregon, 97701

  • Medispect

    Boone, North Carolina, 28607

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Connecticut Clinical Research Foundation CT Gastroenterology Institute At Bristol Hospital

    Bristol, Connecticut, 06010

  • Life Medi-Research and Management

    Brooklyn, New York, 11206

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Metropolitan Gastroenterology Group, Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • South Lake Pain Institute

    Clermont, Florida, 34711

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Arrowhead Regional Medical Center

    Colton, California, 92324

  • Gastro Center of Maryland

    Columbia, Maryland, 21045

  • The Corvallis Clinic, Clinical Research Center

    Corvallis, Oregon, 97330

  • Research Across America

    Dallas, Texas, 75010

  • Dayton Gastroenterology, Inc.

    Dayton, Ohio, 45415

  • Atlanta Center for Gastroenterology

    Decatur, Georgia, 30033

  • Rocky Mountain Clinical Research, LLC

    Denver, Colorado, 80229

  • Duke University

    Durham, North Carolina, 27710

  • North Shore University Health System

    Evanston, Illinois, 60201

  • Womack Army Medical Center

    Fort Bragg, North Carolina, 28310-7301

  • Meritus Center For Clinical Research

    Hagerstown, Maryland, 21742

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Private Practice

    Hollywood, Florida, 33021

  • Research Concepts, GP LLC

    Houston, Texas, 77024

  • University of TX Affiliated Hospitals

    Houston, Texas, 77030

  • Houston Endoscopy and Research Center

    Houston, Texas, 77079

  • Houston Digestive Disease Clinic

    Houston, Texas, 77090-3408

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Kendrick Regional Medical Center

    Indianapolis, Indiana, 46237

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • CRC of Jackson

    Jackson, Mississippi, 39202

  • HCCA Clinical Research Solutions

    Jackson, Tennessee, 38305

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65109

  • UC San Diego

    La Jolla, California, 92093

  • Alliance Research Centers

    Laguna Hills, California, 92653

  • Impact Clinical Trials

    Las Vegas, Nevada, 89106

  • Midwest Center for Clinical Research

    Lee's Summit, Missouri, 64064

  • Axis Clinical Trials

    Los Angeles, California, 90036

  • Cedars Sinai

    Los Angeles, California, 90048

  • Gastrointestinal Biosciences

    Los Angeles, California, 90067

  • University of Louisville

    Louisville, Kentucky, 40202-1622

  • Gastrointestinal Specialist of Georgia

    Marietta, Georgia, 30060

  • Great Lakes Gastroenterology

    Mentor, Ohio, 44060

  • Advance Medical Research Center

    Miami, Florida, 33135

  • Well Pharma Medical Research Corp.

    Miami, Florida, 33143

  • Akta Medika

    Miami Beach, Florida, 33140

  • Medical College of Wisconsin Department of Surgery

    Milwaukee, Wisconsin, 53226

  • Surgical Association of Mobile

    Mobile, Alabama, 36607

  • University of South Alabama

    Mobile, Alabama, 36617

  • Delta Research Partners

    Monroe, Louisiana, 71201

  • West Penn Allegheny Health System

    Monroeville, Pennsylvania, 15146

  • Montgomery Women's Health Association, PC

    Montgomery, Alabama, 36117

  • Gastroenterology Group of Naples, PA

    Naples, Florida, 34102

  • Vanderbilt Univ Dept of Colon and Rectal Surgery

    Nashville, Tennessee, 37232

  • Ochsner

    New Orleans, Louisiana, 70121

  • HCCA Clinical Research Solutions

    New York, New York, 10016

  • Manhattan Surgical Associates, LLP

    New York, New York, 10021

  • Colorectal Associates of NY

    New York, New York, 10022

  • Medical Research Associates of New York (New York Gastroenterology Associates, LLP)

    New York, New York, 10075

  • Pain Specialists of Charleston

    North Charleston, South Carolina, 29406

  • Healthcare Clinical Data, Inc.

    North Miami, Florida, 33161

  • Institute of Pain Research

    Oklahoma City, Oklahoma, 73104

  • Colon and Rectal Surgery, Inc

    Omaha, Nebraska, 68114

  • University of California - Irvine Medical Center

    Orange, California, 92868

  • Gastroenterology Associates of Orangeburg, PA

    Orangeburg, South Carolina, 29118

  • Private Practice

    Pembroke Pines, Florida, 33024

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19017

  • Drexel Univ College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Temple University Physicians, Jeanes Hospital

    Philadelphia, Pennsylvania, 19111

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • Westover Heights Clinic

    Portland, Oregon, 97210

  • Premier Medical Group

    Poughkeepsie, New York, 12601

  • Colorado Research Works

    Pueblo, Colorado, 81008

  • University of North Carolina

    Raleigh, North Carolina, 27599

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Jefferson Surgical Clinic

    Roanoke, Virginia, 24016

  • University of Utah HSC

    Salt Lake City, Utah, 84132

  • Digestive Care Associated, A Medical Corporation

    San Carlos, California, 94070

  • ColoProctology Associates

    Seabrook, Texas, 77586

  • Digestive Disease Institute, Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Baystate Medical Center Department of Surgery

    Springfield, Massachusetts, 01199

  • Atlanta Gastroenterology Consultants

    Suwanee, Georgia, 30024

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

  • University of South Florida, South Campus

    Tampa, Florida, 33606

  • West Coast Clinical Research

    Tarzana, California, 91356

  • Rocky Mountain Clinical Research, LLC

    Thornton, Colorado, 80229

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Desert Sun Clinical Research, LLC

    Tucson, Arizona, 85710

  • Gastroenterology Group & Endoscopy Center of South NJ (GGSJ)

    Vineland, New Jersey, 08360-7072

  • C&R Surgical Assoc of South Jersey

    Voorhees Township, New Jersey, 08043-9544

  • Washington Hospital Center - MedStar Health Research Institute

    Washington D.C., District of Columbia, 20010

  • Trial Management Associates

    Wilmington, North Carolina, 28403

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33542

Other trials in United States

About this study

Official title: A Phase 3B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Topical Diltiazem Hydrochloride 2% Cream in Subjects With Anal Fissure

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.

Read the 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.

Being tested
VEN 307, Placebo
Keywords
Anal, Fissure, Pain
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VEN 307Drug

    Also called diltiazem hydrochloride 2% cream

    VEN307 applied three times a day, in and around the anus, for 28 days.

  • PlaceboDrug

    Also called Placebo cream

    Placebo cream applied three times a day, in and around the anus, for 28 days.

Study groups in NCT01690221
Study groupRoleWhat they receive
VEN 307Experimentaldiltiazem hydrochloride 2% cream
Receives: Drug: VEN 307
PlaceboPlacebo comparatorPlacebo Cream
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2013
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
434 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01690221
Sponsor's protocol ID
VEN307-AF-001
Status last verified
Jan 2014
First submitted
17 Sep 2012
Last updated
23 Jan 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VEN 307 in people with Chronic Anal Fissures, run by Ventrus Biosciences, Inc at 103 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01690221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014.

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