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

NCT01690221 | Completed Phase 3

• 1 other identifier: VEN307-AF-001
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 103

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.

Conditions

Chronic Anal Fissures

Keywords

Anal; Fissure; Pain

Outcome Measures

Primary Outcomes (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).

  28 days

Study Arms (2)

VEN 307

EXPERIMENTAL

diltiazem hydrochloride 2% cream

Drug: VEN 307

Placebo

PLACEBO COMPARATOR

Placebo Cream

Drug: Placebo

Interventions

VEN 307 DRUG

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

Also known as: diltiazem hydrochloride 2% cream

VEN 307

Placebo DRUG

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

Also known as: Placebo cream

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Ventrus Biosciences, Inc: lead

Study Sites (103)

The Crawford Clinic

Anniston, Alabama, 36207, United States

Location

Surgical Association of Mobile

Mobile, Alabama, 36607, United States

Location

University of South Alabama

Mobile, Alabama, 36617, United States

Location

Montgomery Women's Health Association, PC

Montgomery, Alabama, 36117, United States

Location

Mayo Clinic - Arizona

Phoenix, Arizona, 85054, United States

Location

Desert Sun Clinical Research, LLC

Tucson, Arizona, 85710, United States

Location

Arrowhead Regional Medical Center

Colton, California, 92324, United States

Location

UC San Diego

La Jolla, California, 92093, United States

Location

Alliance Research Centers

Laguna Hills, California, 92653, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Cedars Sinai

Los Angeles, California, 90048, United States

Location

Gastrointestinal Biosciences

Los Angeles, California, 90067, United States

Location

University of California - Irvine Medical Center

Orange, California, 92868, United States

Location

Digestive Care Associated, A Medical Corporation

San Carlos, California, 94070, United States

Location

West Coast Clinical Research

Tarzana, California, 91356, United States

Location

Rocky Mountain Clinical Research, LLC

Denver, Colorado, 80229, United States

Location

Colorado Research Works

Pueblo, Colorado, 81008, United States

Location

Rocky Mountain Clinical Research, LLC

Thornton, Colorado, 80229, United States

Location

Connecticut Clinical Research Foundation CT Gastroenterology Institute At Bristol Hospital

Bristol, Connecticut, 06010, United States

Location

Washington Hospital Center - MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Innovative Medical Research of South Florida

Aventura, Florida, 33160, United States

Location

South Lake Pain Institute

Clermont, Florida, 34711, United States

Location

Private Practice

Hollywood, Florida, 33021, United States

Location

Advance Medical Research Center

Miami, Florida, 33135, United States

Location

Well Pharma Medical Research Corp.

Miami, Florida, 33143, United States

Location

Akta Medika

Miami Beach, Florida, 33140, United States

Location

Gastroenterology Group of Naples, PA

Naples, Florida, 34102, United States

Location

Healthcare Clinical Data, Inc.

North Miami, Florida, 33161, United States

Location

Private Practice

Pembroke Pines, Florida, 33024, United States

Location

Advanced Medical Research Center

Port Orange, Florida, 32127, United States

Location

University of South Florida, South Campus

Tampa, Florida, 33606, United States

Location

Florida Medical Clinic, P.A.

Zephyrhills, Florida, 33542, United States

Location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

Atlanta Center for Gastroenterology

Decatur, Georgia, 30033, United States

Location

Gastrointestinal Specialist of Georgia

Marietta, Georgia, 30060, United States

Location

Atlanta Gastroenterology Consultants

Suwanee, Georgia, 30024, United States

Location

NCH Medical Group

Arlington Heights, Illinois, 60004, United States

Location

North Shore University Health System

Evanston, Illinois, 60201, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Kendrick Regional Medical Center

Indianapolis, Indiana, 46237, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Louisville

Louisville, Kentucky, 40202-1622, United States

Location

Delta Research Partners

Monroe, Louisiana, 71201, United States

Location

Ochsner

New Orleans, Louisiana, 70121, United States

Location

Investigative Clinical Research

Annapolis, Maryland, 21401, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Metropolitan Gastroenterology Group, Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Gastro Center of Maryland

Columbia, Maryland, 21045, United States

Location

Meritus Center For Clinical Research

Hagerstown, Maryland, 21742, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Baystate Medical Center Department of Surgery

Springfield, Massachusetts, 01199, United States

Location

Center for Digestive Health

Troy, Michigan, 48098, United States

Location

CRC of Jackson

Jackson, Mississippi, 39202, United States

Location

Jefferson City Medical Group

Jefferson City, Missouri, 65109, United States

Location

Midwest Center for Clinical Research

Lee's Summit, Missouri, 64064, United States

Location

Colon and Rectal Surgery, Inc

Omaha, Nebraska, 68114, United States

Location

Impact Clinical Trials

Las Vegas, Nevada, 89106, United States

Location

Gastroenterology Group & Endoscopy Center of South NJ (GGSJ)

Vineland, New Jersey, 08360-7072, United States

Location

C&R Surgical Assoc of South Jersey

Voorhees Township, New Jersey, 08043-9544, United States

Location

Life Medi-Research and Management

Brooklyn, New York, 11206, United States

Location

HCCA Clinical Research Solutions

New York, New York, 10016, United States

Location

Manhattan Surgical Associates, LLP

New York, New York, 10021, United States

Location

Colorectal Associates of NY

New York, New York, 10022, United States

Location

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

New York, New York, 10075, United States

Location

Premier Medical Group

Poughkeepsie, New York, 12601, United States

Location

Medispect

Boone, North Carolina, 28607, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Womack Army Medical Center

Fort Bragg, North Carolina, 28310-7301, United States

Location

University of North Carolina

Raleigh, North Carolina, 27599, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Trial Management Associates

Wilmington, North Carolina, 28403, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Dayton Gastroenterology, Inc.

Dayton, Ohio, 45415, United States

Location

Great Lakes Gastroenterology

Mentor, Ohio, 44060, United States

Location

Institute of Pain Research

Oklahoma City, Oklahoma, 73104, United States

Location

Bend Memorial Clinic

Bend, Oregon, 97701, United States

Location

The Corvallis Clinic, Clinical Research Center

Corvallis, Oregon, 97330, United States

Location

Westover Heights Clinic

Portland, Oregon, 97210, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

West Penn Allegheny Health System

Monroeville, Pennsylvania, 15146, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19017, United States

Location

Drexel Univ College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Temple University Physicians, Jeanes Hospital

Philadelphia, Pennsylvania, 19111, United States

Location

Pain Specialists of Charleston

North Charleston, South Carolina, 29406, United States

Location

Gastroenterology Associates of Orangeburg, PA

Orangeburg, South Carolina, 29118, United States

Location

HCCA Clinical Research Solutions

Jackson, Tennessee, 38305, United States

Location

Vanderbilt Univ Dept of Colon and Rectal Surgery

Nashville, Tennessee, 37232, United States

Location

Research Across America

Dallas, Texas, 75010, United States

Location

Research Concepts, GP LLC

Houston, Texas, 77024, United States

Location

University of TX Affiliated Hospitals

Houston, Texas, 77030, United States

Location

Houston Endoscopy and Research Center

Houston, Texas, 77079, United States

Location

Houston Digestive Disease Clinic

Houston, Texas, 77090-3408, United States

Location

ColoProctology Associates

Seabrook, Texas, 77586, United States

Location

University of Utah HSC

Salt Lake City, Utah, 84132, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

Jefferson Surgical Clinic

Roanoke, Virginia, 24016, United States

Location

NW Gastroenterology

Bellevue, Washington, 98004, United States

Location

Digestive Disease Institute, Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Medical College of Wisconsin Department of Surgery

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Diltiazem

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 21, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

US (103)