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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486031
• Other study ID #: BZUC3005
• Status: Completed
• Phase: Phase 3
• Start date: October 2006
• Est. completion date: December 2008

Study information

• Verified date: August 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: December 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Balsalazide Disodium

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent AEs	Incidence of treatment emergent adverse events	24 Months
Secondary	Time to Onset of AEs	Time to onset of adverse events	24 Months