Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
A Multicenter, Open-label Trials to Evaluate the Long-term Safety and Tolerability of a New Balsalazide Disodium Tablet Formulation in Patients With Ulcerative Colitis
1 other identifier
interventional
443
1 country
95
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2006
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 11, 2007
CompletedFirst Posted
Study publicly available on registry
June 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
January 19, 2018
CompletedAugust 15, 2019
August 1, 2019
1.5 years
June 11, 2007
December 19, 2017
August 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment Emergent AEs
Incidence of treatment emergent adverse events
24 Months
Secondary Outcomes (1)
Time to Onset of AEs
24 Months
Study Arms (1)
balsalazide disodium tablets,3.3 g BID,
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (95)
Birmingham Gastroenterology Associates, PC
Birmingham, Alabama, 35209, United States
Premeire Pharmaceutical Research
Tempe, Arizona, 85282, United States
Medical Services of NWA
Fayetteville, Arkansas, 72703, United States
AGMG Clinical Research Institute
Anaheim, California, 92801, United States
Discovery Clinical Research, Inc.
Encinitas, California, 92024, United States
Digestive and Liver Disease Specialists
Garden Grove, California, 92840, United States
West Gastroenterology Medical Group
Los Angeles, California, 90045, United States
Community Clinical Trials
Orange, California, 92868, United States
Sharp Rees-Stealy Medical
San Diego, California, 92101, United States
Rocky Mountain Gastroenterology
Lakewood, Colorado, 80215, United States
Arapahoe Gastrroenterology, PC
Littleton, Colorado, 80120, United States
South Denver Gastroenterology
Lone Tree, Colorado, 80124, United States
Connecticut Gastroenterology Institute
Bristol, Connecticut, 06010, United States
Clinical Trials Management of Boca Raton
Boca Raton, Florida, 33486, United States
Research Consultants Group
Hialeah, Florida, 33010, United States
Horizon Institute for Clinical Research
Hollywood, Florida, 33021, United States
Mark Lamet, M.D.
Hollywood, Florida, 33021, United States
Southern Clinical Research Consultants
Hollywood, Florida, 33021, United States
A+ Research
Miami, Florida, 33155, United States
United Medical Research
New Smyrna Beach, Florida, 32168, United States
Venture Research Institute, LLC
North Miami Beach, Florida, 33162, United States
West Wind'r Research & Development
Tampa, Florida, 33607, United States
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Dekalb Gastroenterology Associates
Decatur, Georgia, 30033, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201, United States
Digestive Research Associates
Newnan, Georgia, 30263, United States
University Digestive Health Center
Oak Forest, Illinois, 60452, United States
Carle Clinic Association
Urbana, Illinois, 61801, United States
Community Clinical Research Center
Anderson, Indiana, 46011, United States
Iowa Digestive Disease Center, PC
Clive, Iowa, 50325, United States
Cotton-O'Neil Digestive Health Center
Topeka, Kansas, 66606, United States
Digestive Health Center of Louisiana
Baton Rouge, Louisiana, 70809, United States
Clinical Trials Management
Metairie, Louisiana, 70006', United States
Digestive Disorders Associates
Annapolis, Maryland, 21401, United States
Alan Rosen, M.D.
Baltimore, Maryland, 21215, United States
Digestive Disease Association
Baltimore, Maryland, 21229, United States
Metro Gastroenterology Group
Chevy Chase, Maryland, 20815, United States
Washington County Hospital
Hagerstown, Maryland, 21740, United States
Philip J. Bean Medical Center
Hollywood, Maryland, 20636, United States
Charm City Research
Lutherville, Maryland, 21093, United States
Coastal Research Associates, Inc.
Braintree, Massachusetts, 02184, United States
Clinical Research Institute of Michigan LLC
Chesterfield, Michigan, 48047, United States
Gastroenterology Associates of West Michigan
Grand Rapids, Michigan, 49506, United States
Gastrointestinal Associates
Jackson, Mississippi, 39202, United States
Center for Digestive and Liver Diseases
Mexico, Missouri, 65265, United States
St. Louis Center for Clinical Research
St Louis, Missouri, 63128, United States
Central Jersey Medical Research
Elizabeth, New Jersey, 07202, United States
Shore Health Group
Ocean City, New Jersey, 07712, United States
The GI Group of South Jersey
Vineland, New Jersey, 08360, United States
Long Island Clinical Research
Great Neck, New York, 11021, United States
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, 10021, United States
Simon Lichtiger, MD
New York, New York, 10128, United States
Stony Brook University Hospital
Stony Brook, New York, 11794-8173, United States
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina, 28207, United States
Northwest Piedmont Clinical Research
Elkin, North Carolina, 28621, United States
LeBauer Research Associates, PA
Greensboro, North Carolina, 27403, United States
Carolina Digestive Diseases, PA
Greenville, North Carolina, 27834, United States
East Carolina Gastroenterology, PA
Jacksonville, North Carolina, 28546, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Hanover Medical Specialists, PA
Wilmington, North Carolina, 28401, United States
Wilmington Gastroenterology Associates
Wilmington, North Carolina, 28403, United States
Digestive Health Specialists
Winston-Salem, North Carolina, 27103, United States
Gastroenterology Specialists, Inc.
Canton, Ohio, 44718, United States
Consultants for Clinical Research, Inc.
Cincinnati, Ohio, 45219, United States
Digestive Health Newtork
Cincinnati, Ohio, 45220, United States
Gastrointestinal & Liver Disease Consultants
Dayton, Ohio, 45410, United States
Avamar Center for Endoscopy
Warren, Ohio, 44484, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Gastroenterology United of Tulsa
Tulsa, Oklahoma, 74135, United States
George Koval, M.D.
Portland, Oregon, 97225, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Guthrie Clinic, Ltd
Sayre, Pennsylvania, 18840, United States
Charleston Gastroenterology Center
Charleston, South Carolina, 29414, United States
ClinSearch
Chattanooga, Tennessee, 37404, United States
Memphis Gastroenterology Group
Memphis, Tennessee, 38138, United States
Gastrointestinal Institute, PLLC
Nashville, Tennessee, 37203, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Austin Gastroenterology
Austin, Texas, 78745, United States
NationsMed Clinical Research
Houston, Texas, 77036, United States
Houston Digestive Diseases Clinic
Houston, Texas, 77090, United States
Houston Medical Research Associates
Houston, Texas, 77090, United States
Baylor University Medical Center
Irving, Texas, 75601, United States
North Texas Gastroenterology
Lewisville, Texas, 75057, United States
Gastroenterology Clinic of San Antonio
San Antonio, Texas, 78229, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
McGuire VAMC
Richmond, Virginia, 23249, United States
Seattle Gastroenterology Associates
Seattle, Washington, 98133, United States
Tacoma Digestive Disease Research
Tacoma, Washington, 98405, United States
Discovery Research International
Milwaukee, Wisconsin, 53215, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Johnson Varughese
- Organization
- Valeant Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2007
First Posted
June 13, 2007
Study Start
October 1, 2006
Primary Completion
April 1, 2008
Study Completion
December 1, 2008
Last Updated
August 15, 2019
Results First Posted
January 19, 2018
Record last verified: 2019-08