Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study

Last updated: August 1, 2019
Sponsor: Bausch Health Americas, Inc.
Overall Status: Completed

Phase

3

Condition

Inflammatory Bowel Disease

Ulcerative Colitis

Crohn's Disease (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00486031
BZUC3005
  • Ages > 18
  • All Genders

Study Summary

The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has a documented history of UC and is either in remission or currentlypresents with mildly to moderately active UC symptoms as determined by theinvestigator upon subject interview of UC symptoms, (e.g., urgency, bowel frequency,and rectal bleeding). Additionally, the diagnosis of UC must be confirmed by pastflexible sigmoidoscopy/colonoscopy which may include colonic mucosal pathologicalfindings on biopsy consistent with UC.

  • Subject is capable and willing to comply with all study procedures.

Exclusion

Exclusion Criteria:

  • Subject has a history of allergy or intolerance to aspirin, mesalamine or othersalicylates.

  • Subject has participated in an investigational drug or device study, other than aprevious balsalazide disodium tablet trial (i.e., BZUC3002 or BZUC3003), within 30days of entering the current study.

  • Subject discontinued from a previous balsalazide disodium tablet study due to studydrug-related AE(s), including UC flare or associated symptoms that were perceived bythe subject/investigator as being caused by study drug.

  • Subject has had any prior bowel surgery, except appendectomy and cholecystectomy.

  • Subject has unstable cardiovascular, coagulopathy, or pulmonary disease.

  • Regular use of nonsteroidal anti-inflammatory drugs (NSAIDS) except cardioprotectiveASA (i.e., less than or equal to 162 mg ASA per day).

  • Subject has a history of human immunodeficiency virus (HIV) or hepatitis (B and C).Subjects with a history of hepatitis B and C will be eligible provided the screeningLFTs are within normal limits.

Study Design

Total Participants: 443
Study Start date:
October 01, 2006
Estimated Completion Date:
December 31, 2008

Study Description

The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.

Connect with a study center

  • Birmingham Gastroenterology Associates, PC

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Premeire Pharmaceutical Research

    Tempe, Arizona 85282
    United States

    Site Not Available

  • Medical Services of NWA

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • AGMG Clinical Research Institute

    Anaheim, California 92801
    United States

    Site Not Available

  • Discovery Clinical Research, Inc.

    Encinitas, California 92024
    United States

    Site Not Available

  • Digestive and Liver Disease Specialists

    Garden Grove, California 92840
    United States

    Site Not Available

  • West Gastroenterology Medical Group

    Los Angeles, California 90045
    United States

    Site Not Available

  • Community Clinical Trials

    Orange, California 92868
    United States

    Site Not Available

  • Sharp Rees-Stealy Medical

    San Diego, California 92101
    United States

    Site Not Available

  • Rocky Mountain Gastroenterology

    Lakewood, Colorado 80215
    United States

    Site Not Available

  • Arapahoe Gastrroenterology, PC

    Littleton, Colorado 80120
    United States

    Site Not Available

  • South Denver Gastroenterology

    Lone Tree, Colorado 80124
    United States

    Site Not Available

  • Connecticut Gastroenterology Institute

    Bristol, Connecticut 06010
    United States

    Site Not Available

  • Clinical Trials Management of Boca Raton

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Research Consultants Group

    Hialeah, Florida 33010
    United States

    Site Not Available

  • Horizon Institute for Clinical Research

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Mark Lamet, M.D.

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Southern Clinical Research Consultants

    Hollywood, Florida 33021
    United States

    Site Not Available

  • A+ Research

    Miami, Florida 33155
    United States

    Site Not Available

  • United Medical Research

    New Smyrna Beach, Florida 32168
    United States

    Site Not Available

  • Venture Research Institute, LLC

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • West Wind'r Research & Development

    Tampa, Florida 33607
    United States

    Site Not Available

  • Shafran Gastroenterology Center

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Florida Medical Clinic, PA

    Zephyrhills, Florida 33542
    United States

    Site Not Available

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Dekalb Gastroenterology Associates

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia 31201
    United States

    Site Not Available

  • Digestive Research Associates

    Newnan, Georgia 30263
    United States

    Site Not Available

  • University Digestive Health Center

    Oak Forest, Illinois 60452
    United States

    Site Not Available

  • Carle Clinic Association

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Community Clinical Research Center

    Anderson, Indiana 46011
    United States

    Site Not Available

  • Iowa Digestive Disease Center, PC

    Clive, Iowa 50325
    United States

    Site Not Available

  • Cotton-O'Neil Digestive Health Center

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Digestive Health Center of Louisiana

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Clinical Trials Management

    Metairie, Louisiana 70006`
    United States

    Site Not Available

  • Digestive Disorders Associates

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Alan Rosen, M.D.

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Digestive Disease Association

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Metro Gastroenterology Group

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Washington County Hospital

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Philip J. Bean Medical Center

    Hollywood, Maryland 20636
    United States

    Site Not Available

  • Charm City Research

    Lutherville, Maryland 21093
    United States

    Site Not Available

  • Coastal Research Associates, Inc.

    Braintree, Massachusetts 02184
    United States

    Site Not Available

  • Clinical Research Institute of Michigan LLC

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Gastroenterology Associates of West Michigan

    Grand Rapids, Michigan 49506
    United States

    Site Not Available

  • Gastrointestinal Associates

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • Center for Digestive and Liver Diseases

    Mexico, Missouri 65265
    United States

    Site Not Available

  • St. Louis Center for Clinical Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • St. Louis Center for Clinical Research

    St. Louis, Missouri 63128
    United States

    Site Not Available

  • Central Jersey Medical Research

    Elizabeth, New Jersey 07202
    United States

    Site Not Available

  • Shore Health Group

    Ocean, New Jersey 07712
    United States

    Site Not Available

  • Shore Health Group

    Ocean City, New Jersey 07712
    United States

    Site Not Available

  • The GI Group of South Jersey

    Vineland, New Jersey 08360
    United States

    Site Not Available

  • Long Island Clinical Research

    Great Neck, New York 11021
    United States

    Site Not Available

  • New York Presbyterian Hospital-Weill Medical College of Cornell University

    New York, New York 10021
    United States

    Site Not Available

  • Simon Lichtiger, MD

    New York, New York 10128
    United States

    Site Not Available

  • Stony Brook University Hospital

    Stony Brook, New York 11794-8173
    United States

    Site Not Available

  • Charlotte Gastroenterology & Hepatology

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Northwest Piedmont Clinical Research

    Elkin, North Carolina 28621
    United States

    Site Not Available

  • LeBauer Research Associates, PA

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • Carolina Digestive Diseases, PA

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • East Carolina Gastroenterology, PA

    Jacksonville, North Carolina 28546
    United States

    Site Not Available

  • Wake Research Associates

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Hanover Medical Specialists, PA

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Wilmington Gastroenterology Associates

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Digestive Health Specialists

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Gastroenterology Specialists, Inc.

    Canton, Ohio 44718
    United States

    Site Not Available

  • Consultants for Clinical Research, Inc.

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Digestive Health Newtork

    Cincinnati, Ohio 45220
    United States

    Site Not Available

  • Gastrointestinal & Liver Disease Consultants

    Dayton, Ohio 45410
    United States

    Site Not Available

  • Avamar Center for Endoscopy

    Warren, Ohio 44484
    United States

    Site Not Available

  • Sooner Clinical Research

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Gastroenterology United of Tulsa

    Tulsa, Oklahoma 74135
    United States

    Site Not Available

  • George Koval, M.D.

    Portland, Oregon 97225
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Guthrie Clinic, Ltd

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Charleston Gastroenterology Center

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • ClinSearch

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Memphis Gastroenterology Group

    Memphis, Tennessee 38138
    United States

    Site Not Available

  • Gastrointestinal Institute, PLLC

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Nashville Medical Research Institute

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Austin Gastroenterology

    Austin, Texas 78745
    United States

    Site Not Available

  • Houston Digestive Diseases Clinic

    Houston, Texas 77090
    United States

    Site Not Available

  • Houston Medical Research Associates

    Houston, Texas 77090
    United States

    Site Not Available

  • NationsMed Clinical Research

    Houston, Texas 77036
    United States

    Site Not Available

  • Baylor University Medical Center

    Irving, Texas 75601
    United States

    Site Not Available

  • North Texas Gastroenterology

    Lewisville, Texas 75057
    United States

    Site Not Available

  • Gastroenterology Clinic of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Advanced Research Institute

    Ogden, Utah 84405
    United States

    Site Not Available

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia 23320
    United States

    Site Not Available

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • McGuire VAMC

    Richmond, Virginia 23249
    United States

    Site Not Available

  • Seattle Gastroenterology Associates

    Seattle, Washington 98133
    United States

    Site Not Available

  • Tacoma Digestive Disease Research

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Discovery Research International

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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