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

NCT ID: NCT00486031

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 443 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-12-31

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.

Conditions

Inflammatory Bowel Disease; Ulcerative Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

balsalazide disodium tablets,3.3 g BID,

Group Type: OTHER

Balsalazide Disodium

Intervention Type: DRUG

Interventions

Balsalazide Disodium

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham Gastroenterology Associates, PC

Birmingham, Alabama, United States

Premeire Pharmaceutical Research

Tempe, Arizona, United States

Medical Services of NWA

Fayetteville, Arkansas, United States

AGMG Clinical Research Institute

Anaheim, California, United States

Discovery Clinical Research, Inc.

Encinitas, California, United States

Digestive and Liver Disease Specialists

Garden Grove, California, United States

West Gastroenterology Medical Group

Los Angeles, California, United States

Community Clinical Trials

Orange, California, United States

Sharp Rees-Stealy Medical

San Diego, California, United States

Rocky Mountain Gastroenterology

Lakewood, Colorado, United States

Arapahoe Gastrroenterology, PC

Littleton, Colorado, United States

South Denver Gastroenterology

Lone Tree, Colorado, United States

Connecticut Gastroenterology Institute

Bristol, Connecticut, United States

Clinical Trials Management of Boca Raton

Boca Raton, Florida, 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

Southern Clinical Research Consultants

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

West Wind'r Research & Development

Tampa, Florida, United States

Shafran Gastroenterology Center

Winter Park, Florida, United States

Florida Medical Clinic, PA

Zephyrhills, Florida, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Dekalb Gastroenterology Associates

Decatur, Georgia, United States

Gastroenterology Associates of Central Georgia

Macon, 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

Community Clinical Research Center

Anderson, Indiana, United States

Iowa Digestive Disease Center, PC

Clive, Iowa, United States

Cotton-O'Neil Digestive Health Center

Topeka, Kansas, United States

Digestive Health Center of Louisiana

Baton Rouge, Louisiana, United States

Clinical Trials Management

Metairie, Louisiana, United States

Digestive Disorders Associates

Annapolis, Maryland, United States

Alan Rosen, M.D.

Baltimore, Maryland, United States

Digestive Disease Association

Baltimore, Maryland, United States

Metro Gastroenterology Group

Chevy Chase, Maryland, United States

Washington County Hospital

Hagerstown, Maryland, United States

Philip J. Bean Medical Center

Hollywood, Maryland, United States

Charm City Research

Lutherville, Maryland, United States

Coastal Research Associates, Inc.

Braintree, Massachusetts, United States

Clinical Research Institute of Michigan LLC

Chesterfield, Michigan, United States

Gastroenterology Associates of West Michigan

Grand Rapids, Michigan, United States

Gastrointestinal Associates

Jackson, Mississippi, United States

Center for Digestive and Liver Diseases

Mexico, Missouri, United States

St. Louis Center for Clinical Research

St Louis, Missouri, United States

Central Jersey Medical Research

Elizabeth, New Jersey, United States

Shore Health Group

Ocean City, New Jersey, United States

The GI Group of South Jersey

Vineland, New Jersey, United States

Long Island Clinical Research

Great Neck, New York, 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

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

LeBauer Research Associates, PA

Greensboro, North Carolina, United States

Carolina Digestive Diseases, PA

Greenville, North Carolina, United States

East Carolina Gastroenterology, PA

Jacksonville, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, 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

Gastroenterology Specialists, Inc.

Canton, Ohio, United States

Consultants for Clinical Research, Inc.

Cincinnati, 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

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

Gastroenterology United of Tulsa

Tulsa, Oklahoma, United States

George Koval, M.D.

Portland, Oregon, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Guthrie Clinic, Ltd

Sayre, Pennsylvania, United States

Charleston Gastroenterology Center

Charleston, South Carolina, United States

ClinSearch

Chattanooga, Tennessee, United States

Memphis Gastroenterology Group

Memphis, Tennessee, United States

Gastrointestinal Institute, PLLC

Nashville, Tennessee, United States

Nashville Medical Research Institute

Nashville, Tennessee, United States

Austin Gastroenterology

Austin, Texas, United States

NationsMed Clinical Research

Houston, Texas, United States

Houston Digestive Diseases Clinic

Houston, Texas, United States

Houston Medical Research Associates

Houston, Texas, United States

Baylor University Medical Center

Irving, Texas, United States

North Texas Gastroenterology

Lewisville, Texas, United States

Gastroenterology Clinic of San Antonio

San Antonio, Texas, United States

Advanced Research Institute

Ogden, Utah, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Digestive and Liver Disease Specialists

Norfolk, Virginia, United States

McGuire VAMC

Richmond, Virginia, United States

Seattle Gastroenterology Associates

Seattle, Washington, United States

Tacoma Digestive Disease Research

Tacoma, Washington, United States

Discovery Research International

Milwaukee, Wisconsin, United States

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

BZUC3005

Identifier Type: -

Identifier Source: org_study_id