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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis; Inflammatory Bowel Disease
• Intervention / Treatment: Drug: Balsalazide Disodium

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.

• Study Type: Interventional
• Enrollment (Actual): 443
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Birmingham Gastroenterology Associates, PC
  • Arizona
    • Tempe, Arizona, United States, 85282
      • Premeire Pharmaceutical Research
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Medical Services of NWA
  • California
    • Anaheim, California, United States, 92801
      • AGMG Clinical Research Institute
    • Encinitas, California, United States, 92024
      • Discovery Clinical Research, Inc.
    • Garden Grove, California, United States, 92840
      • Digestive and Liver Disease Specialists
    • Los Angeles, California, United States, 90045
      • West Gastroenterology Medical Group
    • Orange, California, United States, 92868
      • Community Clinical Trials
    • San Diego, California, United States, 92101
      • Sharp Rees-Stealy Medical
  • Colorado
    • Lakewood, Colorado, United States, 80215
      • Rocky Mountain Gastroenterology
    • Littleton, Colorado, United States, 80120
      • Arapahoe Gastrroenterology, PC
    • Lone Tree, Colorado, United States, 80124
      • South Denver Gastroenterology
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Connecticut Gastroenterology Institute
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Clinical Trials Management of Boca Raton
    • Hialeah, Florida, United States, 33010
      • Research Consultants Group
    • Hollywood, Florida, United States, 33021
      • Southern Clinical Research Consultants
    • Hollywood, Florida, United States, 33021
      • Horizon Institute for Clinical Research
    • Hollywood, Florida, United States, 33021
      • Mark Lamet, M.D.
    • Miami, Florida, United States, 33155
      • A+ Research
    • New Smyrna Beach, Florida, United States, 32168
      • United Medical Research
    • North Miami Beach, Florida, United States, 33162
      • Venture Research Institute, LLC
    • Tampa, Florida, United States, 33607
      • West Wind'r Research & Development
    • Winter Park, Florida, United States, 32789
      • Shafran Gastroenterology Center
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, PA
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
    • Decatur, Georgia, United States, 30033
      • Dekalb Gastroenterology Associates
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia
    • Newnan, Georgia, United States, 30263
      • Digestive Research Associates
  • Illinois
    • Oak Forest, Illinois, United States, 60452
      • University Digestive Health Center
    • Urbana, Illinois, United States, 61801
      • Carle Clinic Association
  • Indiana
    • Anderson, Indiana, United States, 46011
      • Community Clinical Research Center
  • Iowa
    • Clive, Iowa, United States, 50325
      • Iowa Digestive Disease Center, PC
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Digestive Health Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Digestive Health Center of Louisiana
    • Metairie, Louisiana, United States, 70006'
      • Clinical Trials Management
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Digestive Disorders Associates
    • Baltimore, Maryland, United States, 21215
      • Alan Rosen, M.D.
    • Baltimore, Maryland, United States, 21229
      • Digestive Disease Association
    • Chevy Chase, Maryland, United States, 20815
      • Metro Gastroenterology Group
    • Hagerstown, Maryland, United States, 21740
      • Washington County Hospital
    • Hollywood, Maryland, United States, 20636
      • Philip J. Bean Medical Center
    • Lutherville, Maryland, United States, 21093
      • Charm City Research
  • Massachusetts
    • Braintree, Massachusetts, United States, 02184
      • Coastal Research Associates, Inc.
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan LLC
    • Grand Rapids, Michigan, United States, 49506
      • Gastroenterology Associates of West Michigan
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Gastrointestinal Associates
  • Missouri
    • Mexico, Missouri, United States, 65265
      • Center for Digestive and Liver Diseases
    • Saint Louis, Missouri, United States, 63128
      • St. Louis Center for Clinical Research
  • New Jersey
    • Elizabeth, New Jersey, United States, 07202
      • Central Jersey Medical Research
    • Ocean City, New Jersey, United States, 07712
      • Shore Health Group
    • Vineland, New Jersey, United States, 08360
      • The GI Group of South Jersey
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital-Weill Medical College of Cornell University
    • New York, New York, United States, 10128
      • Simon Lichtiger, MD
    • Stony Brook, New York, United States, 11794-8173
      • Stony Brook University Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Charlotte Gastroenterology & Hepatology
    • Elkin, North Carolina, United States, 28621
      • Northwest Piedmont Clinical Research
    • Greensboro, North Carolina, United States, 27403
      • LeBauer Research Associates, PA
    • Greenville, North Carolina, United States, 27834
      • Carolina Digestive Diseases, PA
    • Jacksonville, North Carolina, United States, 28546
      • East Carolina Gastroenterology, PA
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Wilmington, North Carolina, United States, 28401
      • Hanover Medical Specialists, PA
    • Wilmington, North Carolina, United States, 28403
      • Wilmington Gastroenterology Associates
    • Winston-Salem, North Carolina, United States, 27103
      • Digestive Health Specialists
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gastroenterology Specialists, Inc.
    • Cincinnati, Ohio, United States, 45219
      • Consultants For Clinical Research, Inc.
    • Cincinnati, Ohio, United States, 45220
      • Digestive Health Newtork
    • Dayton, Ohio, United States, 45410
      • Gastrointestinal & Liver Disease Consultants
    • Warren, Ohio, United States, 44484
      • Avamar Center for Endoscopy
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Sooner Clinical Research
    • Tulsa, Oklahoma, United States, 74135
      • Gastroenterology United of Tulsa
  • Oregon
    • Portland, Oregon, United States, 97225
      • George Koval, M.D.
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Clinic, Ltd
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Gastroenterology Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • ClinSearch
    • Memphis, Tennessee, United States, 38138
      • Memphis Gastroenterology Group
    • Nashville, Tennessee, United States, 37205
      • Nashville Medical Research Institute
    • Nashville, Tennessee, United States, 37203
      • Gastrointestinal Institute, PLLC
  • Texas
    • Austin, Texas, United States, 78745
      • Austin Gastroenterology
    • Houston, Texas, United States, 77090
      • Houston Medical Research Associates
    • Houston, Texas, United States, 77090
      • Houston Digestive Diseases Clinic
    • Houston, Texas, United States, 77036
      • Nationsmed Clinical Research
    • Irving, Texas, United States, 75601
      • Baylor University Medical Center
    • Lewisville, Texas, United States, 75057
      • North Texas Gastroenterology
    • San Antonio, Texas, United States, 78229
      • Gastroenterology Clinic of San Antonio
  • Utah
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists
    • Richmond, Virginia, United States, 23249
      • McGuire VAMC
  • Washington
    • Seattle, Washington, United States, 98133
      • Seattle Gastroenterology Associates
    • Tacoma, Washington, United States, 98405
      • Tacoma Digestive Disease Research
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research
    • Milwaukee, Wisconsin, United States, 53215
      • Discovery Research International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: balsalazide disodium tablets,3.3 g BID,	Drug: Balsalazide Disodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent AEs	Incidence of treatment emergent adverse events	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Onset of AEs	Time to onset of adverse events	24 Months

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: June 11, 2007
• First Submitted That Met QC Criteria: June 11, 2007
• First Posted (Estimate): June 13, 2007

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Inflammatory Bowel Disease; IBD; UC
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Ulcer; Inflammatory Bowel Diseases; Intestinal Diseases; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Balsalazide
• Other Study ID Numbers: BZUC3005