Phase
Condition
Inflammatory Bowel Disease
Ulcerative Colitis
Crohn's Disease (Pediatric)
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Birmingham Gastroenterology Associates, PC
Birmingham, Alabama 35209
United StatesSite Not Available
Premeire Pharmaceutical Research
Tempe, Arizona 85282
United StatesSite Not Available
Medical Services of NWA
Fayetteville, Arkansas 72703
United StatesSite Not Available
AGMG Clinical Research Institute
Anaheim, California 92801
United StatesSite Not Available
Discovery Clinical Research, Inc.
Encinitas, California 92024
United StatesSite Not Available
Digestive and Liver Disease Specialists
Garden Grove, California 92840
United StatesSite Not Available
West Gastroenterology Medical Group
Los Angeles, California 90045
United StatesSite Not Available
Community Clinical Trials
Orange, California 92868
United StatesSite Not Available
Sharp Rees-Stealy Medical
San Diego, California 92101
United StatesSite Not Available
Rocky Mountain Gastroenterology
Lakewood, Colorado 80215
United StatesSite Not Available
Arapahoe Gastrroenterology, PC
Littleton, Colorado 80120
United StatesSite Not Available
South Denver Gastroenterology
Lone Tree, Colorado 80124
United StatesSite Not Available
Connecticut Gastroenterology Institute
Bristol, Connecticut 06010
United StatesSite Not Available
Clinical Trials Management of Boca Raton
Boca Raton, Florida 33486
United StatesSite Not Available
Research Consultants Group
Hialeah, Florida 33010
United StatesSite Not Available
Horizon Institute for Clinical Research
Hollywood, Florida 33021
United StatesSite Not Available
Mark Lamet, M.D.
Hollywood, Florida 33021
United StatesSite Not Available
Southern Clinical Research Consultants
Hollywood, Florida 33021
United StatesSite Not Available
A+ Research
Miami, Florida 33155
United StatesSite Not Available
United Medical Research
New Smyrna Beach, Florida 32168
United StatesSite Not Available
Venture Research Institute, LLC
North Miami Beach, Florida 33162
United StatesSite Not Available
West Wind'r Research & Development
Tampa, Florida 33607
United StatesSite Not Available
Shafran Gastroenterology Center
Winter Park, Florida 32789
United StatesSite Not Available
Florida Medical Clinic, PA
Zephyrhills, Florida 33542
United StatesSite Not Available
Atlanta Gastroenterology Associates
Atlanta, Georgia 30342
United StatesSite Not Available
Dekalb Gastroenterology Associates
Decatur, Georgia 30033
United StatesSite Not Available
Gastroenterology Associates of Central Georgia
Macon, Georgia 31201
United StatesSite Not Available
Digestive Research Associates
Newnan, Georgia 30263
United StatesSite Not Available
University Digestive Health Center
Oak Forest, Illinois 60452
United StatesSite Not Available
Carle Clinic Association
Urbana, Illinois 61801
United StatesSite Not Available
Community Clinical Research Center
Anderson, Indiana 46011
United StatesSite Not Available
Iowa Digestive Disease Center, PC
Clive, Iowa 50325
United StatesSite Not Available
Cotton-O'Neil Digestive Health Center
Topeka, Kansas 66606
United StatesSite Not Available
Digestive Health Center of Louisiana
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Clinical Trials Management
Metairie, Louisiana 70006`
United StatesSite Not Available
Digestive Disorders Associates
Annapolis, Maryland 21401
United StatesSite Not Available
Alan Rosen, M.D.
Baltimore, Maryland 21215
United StatesSite Not Available
Digestive Disease Association
Baltimore, Maryland 21229
United StatesSite Not Available
Metro Gastroenterology Group
Chevy Chase, Maryland 20815
United StatesSite Not Available
Washington County Hospital
Hagerstown, Maryland 21740
United StatesSite Not Available
Philip J. Bean Medical Center
Hollywood, Maryland 20636
United StatesSite Not Available
Charm City Research
Lutherville, Maryland 21093
United StatesSite Not Available
Coastal Research Associates, Inc.
Braintree, Massachusetts 02184
United StatesSite Not Available
Clinical Research Institute of Michigan LLC
Chesterfield, Michigan 48047
United StatesSite Not Available
Gastroenterology Associates of West Michigan
Grand Rapids, Michigan 49506
United StatesSite Not Available
Gastrointestinal Associates
Jackson, Mississippi 39202
United StatesSite Not Available
Center for Digestive and Liver Diseases
Mexico, Missouri 65265
United StatesSite Not Available
St. Louis Center for Clinical Research
Saint Louis, Missouri 63128
United StatesSite Not Available
St. Louis Center for Clinical Research
St. Louis, Missouri 63128
United StatesSite Not Available
Central Jersey Medical Research
Elizabeth, New Jersey 07202
United StatesSite Not Available
Shore Health Group
Ocean, New Jersey 07712
United StatesSite Not Available
Shore Health Group
Ocean City, New Jersey 07712
United StatesSite Not Available
The GI Group of South Jersey
Vineland, New Jersey 08360
United StatesSite Not Available
Long Island Clinical Research
Great Neck, New York 11021
United StatesSite Not Available
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York 10021
United StatesSite Not Available
Simon Lichtiger, MD
New York, New York 10128
United StatesSite Not Available
Stony Brook University Hospital
Stony Brook, New York 11794-8173
United StatesSite Not Available
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina 28207
United StatesSite Not Available
Northwest Piedmont Clinical Research
Elkin, North Carolina 28621
United StatesSite Not Available
LeBauer Research Associates, PA
Greensboro, North Carolina 27403
United StatesSite Not Available
Carolina Digestive Diseases, PA
Greenville, North Carolina 27834
United StatesSite Not Available
East Carolina Gastroenterology, PA
Jacksonville, North Carolina 28546
United StatesSite Not Available
Wake Research Associates
Raleigh, North Carolina 27612
United StatesSite Not Available
Hanover Medical Specialists, PA
Wilmington, North Carolina 28401
United StatesSite Not Available
Wilmington Gastroenterology Associates
Wilmington, North Carolina 28403
United StatesSite Not Available
Digestive Health Specialists
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Gastroenterology Specialists, Inc.
Canton, Ohio 44718
United StatesSite Not Available
Consultants for Clinical Research, Inc.
Cincinnati, Ohio 45219
United StatesSite Not Available
Digestive Health Newtork
Cincinnati, Ohio 45220
United StatesSite Not Available
Gastrointestinal & Liver Disease Consultants
Dayton, Ohio 45410
United StatesSite Not Available
Avamar Center for Endoscopy
Warren, Ohio 44484
United StatesSite Not Available
Sooner Clinical Research
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Gastroenterology United of Tulsa
Tulsa, Oklahoma 74135
United StatesSite Not Available
George Koval, M.D.
Portland, Oregon 97225
United StatesSite Not Available
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Guthrie Clinic, Ltd
Sayre, Pennsylvania 18840
United StatesSite Not Available
Charleston Gastroenterology Center
Charleston, South Carolina 29414
United StatesSite Not Available
ClinSearch
Chattanooga, Tennessee 37404
United StatesSite Not Available
Memphis Gastroenterology Group
Memphis, Tennessee 38138
United StatesSite Not Available
Gastrointestinal Institute, PLLC
Nashville, Tennessee 37203
United StatesSite Not Available
Nashville Medical Research Institute
Nashville, Tennessee 37205
United StatesSite Not Available
Austin Gastroenterology
Austin, Texas 78745
United StatesSite Not Available
Houston Digestive Diseases Clinic
Houston, Texas 77090
United StatesSite Not Available
Houston Medical Research Associates
Houston, Texas 77090
United StatesSite Not Available
NationsMed Clinical Research
Houston, Texas 77036
United StatesSite Not Available
Baylor University Medical Center
Irving, Texas 75601
United StatesSite Not Available
North Texas Gastroenterology
Lewisville, Texas 75057
United StatesSite Not Available
Gastroenterology Clinic of San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
Advanced Research Institute
Ogden, Utah 84405
United StatesSite Not Available
Gastroenterology Associates of Tidewater
Chesapeake, Virginia 23320
United StatesSite Not Available
Digestive and Liver Disease Specialists
Norfolk, Virginia 23502
United StatesSite Not Available
McGuire VAMC
Richmond, Virginia 23249
United StatesSite Not Available
Seattle Gastroenterology Associates
Seattle, Washington 98133
United StatesSite Not Available
Tacoma Digestive Disease Research
Tacoma, Washington 98405
United StatesSite Not Available
Discovery Research International
Milwaukee, Wisconsin 53215
United StatesSite Not Available
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin 53215
United StatesSite Not Available
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