Clinical trial NCT00486031: Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammatory Bowel Disease
Ulcerative Colitis
Keywords: IBD
UC
Ulcerative Colitis
Inflammatory Bowel Disease
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2007-06-13
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of Treatment Emergent AEs
timeFrame: 24 Months
Secondary outcomes:
measure: Time to Onset of AEs
timeFrame: 24 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Gastroenterology Associates, PC
state: Alabama
city: Tempe
country: United States
facility: Premeire Pharmaceutical Research
state: Arizona
city: Fayetteville
country: United States
facility: Medical Services of NWA
state: Arkansas
city: Anaheim
country: United States
facility: AGMG Clinical Research Institute
state: California
city: Encinitas
country: United States
facility: Discovery Clinical Research, Inc.
state: California
city: Garden Grove
country: United States
facility: Digestive and Liver Disease Specialists
state: California
city: Los Angeles
country: United States
facility: West Gastroenterology Medical Group
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical
state: California
city: Lakewood
country: United States
facility: Rocky Mountain Gastroenterology
state: Colorado
city: Littleton
country: United States
facility: Arapahoe Gastrroenterology, PC
state: Colorado
city: Lone Tree
country: United States
facility: South Denver Gastroenterology
state: Colorado
city: Bristol
country: United States
facility: Connecticut Gastroenterology Institute
state: Connecticut
city: Boca Raton
country: United States
facility: Clinical Trials Management of Boca Raton
state: Florida
city: Hialeah
country: United States
facility: Research Consultants Group
state: Florida
city: Hollywood
country: United States
facility: Horizon Institute for Clinical Research
state: Florida
city: Hollywood
country: United States
facility: Mark Lamet, M.D.
state: Florida
city: Hollywood
country: United States
facility: Southern Clinical Research Consultants
state: Florida
city: Miami
country: United States
facility: A+ Research
state: Florida
city: New Smyrna Beach
country: United States
facility: United Medical Research
state: Florida
city: North Miami Beach
country: United States
facility: Venture Research Institute, LLC
state: Florida
city: Tampa
country: United States
facility: West Wind'r Research & Development
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, PA
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Decatur
country: United States
facility: Dekalb Gastroenterology Associates
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Newnan
country: United States
facility: Digestive Research Associates
state: Georgia
city: Oak Forest
country: United States
facility: University Digestive Health Center
state: Illinois
city: Urbana
country: United States
facility: Carle Clinic Association
state: Illinois
city: Anderson
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Clive
country: United States
facility: Iowa Digestive Disease Center, PC
state: Iowa
city: Topeka
country: United States
facility: Cotton-O'Neil Digestive Health Center
state: Kansas
city: Baton Rouge
country: United States
facility: Digestive Health Center of Louisiana
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management
state: Louisiana
city: Annapolis
country: United States
facility: Digestive Disorders Associates
state: Maryland
city: Baltimore
country: United States
facility: Alan Rosen, M.D.
state: Maryland
city: Baltimore
country: United States
facility: Digestive Disease Association
state: Maryland
city: Chevy Chase
country: United States
facility: Metro Gastroenterology Group
state: Maryland
city: Hagerstown
country: United States
facility: Washington County Hospital
state: Maryland
city: Hollywood
country: United States
facility: Philip J. Bean Medical Center
state: Maryland
city: Lutherville
country: United States
facility: Charm City Research
state: Maryland
city: Braintree
country: United States
facility: Coastal Research Associates, Inc.
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan LLC
state: Michigan
city: Grand Rapids
country: United States
facility: Gastroenterology Associates of West Michigan
state: Michigan
city: Jackson
country: United States
facility: Gastrointestinal Associates
state: Mississippi
city: Mexico
country: United States
facility: Center for Digestive and Liver Diseases
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Elizabeth
country: United States
facility: Central Jersey Medical Research
state: New Jersey
city: Ocean City
country: United States
facility: Shore Health Group
state: New Jersey
city: Vineland
country: United States
facility: The GI Group of South Jersey
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Clinical Research
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Medical College of Cornell University
state: New York
city: New York
country: United States
facility: Simon Lichtiger, MD
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hepatology
state: North Carolina
city: Elkin
country: United States
facility: Northwest Piedmont Clinical Research
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Research Associates, PA
state: North Carolina
city: Greenville
country: United States
facility: Carolina Digestive Diseases, PA
state: North Carolina
city: Jacksonville
country: United States
facility: East Carolina Gastroenterology, PA
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Wilmington
country: United States
facility: Hanover Medical Specialists, PA
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Gastroenterology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists
state: North Carolina
city: Canton
country: United States
facility: Gastroenterology Specialists, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Consultants for Clinical Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Digestive Health Newtork
state: Ohio
city: Dayton
country: United States
facility: Gastrointestinal & Liver Disease Consultants
state: Ohio
city: Warren
country: United States
facility: Avamar Center for Endoscopy
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Gastroenterology United of Tulsa
state: Oklahoma
city: Portland
country: United States
facility: George Koval, M.D.
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Clinic, Ltd
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Gastroenterology Center
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Memphis
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Nashville
country: United States
facility: Gastrointestinal Institute, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Gastroenterology
state: Texas
city: Houston
country: United States
facility: NationsMed Clinical Research
state: Texas
city: Houston
country: United States
facility: Houston Digestive Diseases Clinic
state: Texas
city: Houston
country: United States
facility: Houston Medical Research Associates
state: Texas
city: Irving
country: United States
facility: Baylor University Medical Center
state: Texas
city: Lewisville
country: United States
facility: North Texas Gastroenterology
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Clinic of San Antonio
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: McGuire VAMC
state: Virginia
city: Seattle
country: United States
facility: Seattle Gastroenterology Associates
state: Washington
city: Tacoma
country: United States
facility: Tacoma Digestive Disease Research
state: Washington
city: Milwaukee
country: United States
facility: Discovery Research International
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
References: