Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
- Conditions
- Ulcerative ColitisInflammatory Bowel Disease
- Interventions
- Registration Number
- NCT00486031
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 443
- Subject has a documented history of UC and is either in remission or currently presents with mildly to moderately active UC symptoms as determined by the investigator upon subject interview of UC symptoms, (e.g., urgency, bowel frequency, and rectal bleeding). Additionally, the diagnosis of UC must be confirmed by past flexible sigmoidoscopy/colonoscopy which may include colonic mucosal pathological findings on biopsy consistent with UC.
- Subject is capable and willing to comply with all study procedures.
- Subject has a history of allergy or intolerance to aspirin, mesalamine or other salicylates.
- Subject has participated in an investigational drug or device study, other than a previous balsalazide disodium tablet trial (i.e., BZUC3002 or BZUC3003), within 30 days of entering the current study.
- Subject discontinued from a previous balsalazide disodium tablet study due to study drug-related AE(s), including UC flare or associated symptoms that were perceived by the 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 cardioprotective ASA (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 screening LFTs are within normal limits.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description balsalazide disodium tablets,3.3 g BID, Balsalazide Disodium -
- Primary Outcome Measures
Name Time Method Incidence of Treatment Emergent AEs 24 Months Incidence of treatment emergent adverse events
- Secondary Outcome Measures
Name Time Method Time to Onset of AEs 24 Months Time to onset of adverse events
Trial Locations
- Locations (94)
Community Clinical Trials
🇺🇸Orange, California, United States
Premeire Pharmaceutical Research
🇺🇸Tempe, Arizona, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
The GI Group of South Jersey
🇺🇸Vineland, New Jersey, United States
Simon Lichtiger, MD
🇺🇸New York, New York, United States
North Texas Gastroenterology
🇺🇸Lewisville, Texas, United States
West Gastroenterology Medical Group
🇺🇸Los Angeles, California, United States
Houston Digestive Diseases Clinic
🇺🇸Houston, Texas, United States
Digestive Disease Association
🇺🇸Baltimore, Maryland, United States
Digestive Disorders Associates
🇺🇸Annapolis, Maryland, United States
Metro Gastroenterology Group
🇺🇸Chevy Chase, Maryland, United States
Sharp Rees-Stealy Medical
🇺🇸San Diego, California, United States
Consultants for Clinical Research, Inc.
🇺🇸Cincinnati, Ohio, United States
Gastroenterology Clinic of San Antonio
🇺🇸San Antonio, Texas, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Gastrointestinal Institute, PLLC
🇺🇸Nashville, Tennessee, United States
Nashville Medical Research Institute
🇺🇸Nashville, Tennessee, United States
Birmingham Gastroenterology Associates, PC
🇺🇸Birmingham, Alabama, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
George Koval, M.D.
🇺🇸Portland, Oregon, United States
Discovery Research International
🇺🇸Milwaukee, Wisconsin, United States
Clinical Research Institute of Michigan LLC
🇺🇸Chesterfield, Michigan, United States
Gastroenterology United of Tulsa
🇺🇸Tulsa, Oklahoma, United States
Austin Gastroenterology
🇺🇸Austin, Texas, United States
AGMG Clinical Research Institute
🇺🇸Anaheim, California, United States
Discovery Clinical Research, Inc.
🇺🇸Encinitas, California, United States
Arapahoe Gastrroenterology, PC
🇺🇸Littleton, Colorado, United States
South Denver Gastroenterology
🇺🇸Lone Tree, Colorado, United States
Southern Clinical Research Consultants
🇺🇸Hollywood, Florida, United States
Clinical Trials Management of Boca Raton
🇺🇸Boca Raton, Florida, United States
Rocky Mountain Gastroenterology
🇺🇸Lakewood, Colorado, United States
Connecticut Gastroenterology Institute
🇺🇸Bristol, Connecticut, United States
Research Consultants Group
🇺🇸Hialeah, Florida, United States
Mark Lamet, M.D.
🇺🇸Hollywood, Florida, United States
A+ Research
🇺🇸Miami, Florida, United States
United Medical Research
🇺🇸New Smyrna Beach, Florida, United States
Venture Research Institute, LLC
🇺🇸North Miami Beach, Florida, United States
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
Florida Medical Clinic, PA
🇺🇸Zephyrhills, Florida, United States
Dekalb Gastroenterology Associates
🇺🇸Decatur, Georgia, United States
Gastroenterology Associates of Central Georgia
🇺🇸Macon, Georgia, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Digestive Research Associates
🇺🇸Newnan, Georgia, United States
University Digestive Health Center
🇺🇸Oak Forest, Illinois, United States
Carle Clinic Association
🇺🇸Urbana, Illinois, United States
Iowa Digestive Disease Center, PC
🇺🇸Clive, Iowa, United States
Community Clinical Research Center
🇺🇸Anderson, Indiana, United States
Digestive Health Center of Louisiana
🇺🇸Baton Rouge, Louisiana, United States
Clinical Trials Management
🇺🇸Metairie, Louisiana, United States
Charm City Research
🇺🇸Lutherville, Maryland, United States
Washington County Hospital
🇺🇸Hagerstown, Maryland, United States
Alan Rosen, M.D.
🇺🇸Baltimore, Maryland, United States
Philip J. Bean Medical Center
🇺🇸Hollywood, Maryland, United States
Shore Health Group
🇺🇸Ocean City, New Jersey, United States
St. Louis Center for Clinical Research
🇺🇸Saint Louis, Missouri, United States
Coastal Research Associates, Inc.
🇺🇸Braintree, Massachusetts, United States
Gastroenterology Associates of West Michigan
🇺🇸Grand Rapids, Michigan, United States
Center for Digestive and Liver Diseases
🇺🇸Mexico, Missouri, United States
Gastrointestinal Associates
🇺🇸Jackson, Mississippi, United States
Central Jersey Medical Research
🇺🇸Elizabeth, New Jersey, United States
Long Island Clinical Research
🇺🇸Great Neck, New York, United States
LeBauer Research Associates, PA
🇺🇸Greensboro, North Carolina, United States
New York Presbyterian Hospital-Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Charlotte Gastroenterology & Hepatology
🇺🇸Charlotte, North Carolina, United States
Northwest Piedmont Clinical Research
🇺🇸Elkin, North Carolina, United States
East Carolina Gastroenterology, PA
🇺🇸Jacksonville, North Carolina, United States
Carolina Digestive Diseases, PA
🇺🇸Greenville, North Carolina, United States
Hanover Medical Specialists, PA
🇺🇸Wilmington, North Carolina, United States
Wilmington Gastroenterology Associates
🇺🇸Wilmington, North Carolina, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Gastroenterology Specialists, Inc.
🇺🇸Canton, Ohio, United States
Digestive Health Newtork
🇺🇸Cincinnati, Ohio, United States
Gastrointestinal & Liver Disease Consultants
🇺🇸Dayton, Ohio, United States
Avamar Center for Endoscopy
🇺🇸Warren, Ohio, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Guthrie Clinic, Ltd
🇺🇸Sayre, Pennsylvania, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Memphis Gastroenterology Group
🇺🇸Memphis, Tennessee, United States
NationsMed Clinical Research
🇺🇸Houston, Texas, United States
Houston Medical Research Associates
🇺🇸Houston, Texas, United States
Baylor University Medical Center
🇺🇸Irving, Texas, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Tacoma Digestive Disease Research
🇺🇸Tacoma, Washington, United States
Gastroenterology Associates of Tidewater
🇺🇸Chesapeake, Virginia, United States
Seattle Gastroenterology Associates
🇺🇸Seattle, Washington, United States
Horizon Institute for Clinical Research
🇺🇸Hollywood, Florida, United States
West Wind'r Research & Development
🇺🇸Tampa, Florida, United States
Digestive Health Specialists
🇺🇸Winston-Salem, North Carolina, United States
Charleston Gastroenterology Center
🇺🇸Charleston, South Carolina, United States
McGuire VAMC
🇺🇸Richmond, Virginia, United States
Cotton-O'Neil Digestive Health Center
🇺🇸Topeka, Kansas, United States
Medical Services of NWA
🇺🇸Fayetteville, Arkansas, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States