Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis

NCT00408174 | Completed Phase 3

• 1 other identifier: BZUC3003
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 88

Brief Summary

To establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 6 weeks of therapy.

Conditions

Inflammatory Bowel Disease; Ulcerative Colitis

Keywords

IBD; UC; Ulcerative Colitis; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the proportion of subjects that achieve clinical improvement and improvement in the rectal bleeding subscale of the MMDAI at the end of six weeks of therapy.

Interventions

Balsalazide disodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mildly to moderately active ulcerative colitis.
• disease extends at least 20 cm from the rectum.
• baseline MMDAI score between 6-10, inclusive, and greater than or equal to 2 on the MMDAI bleeding component and endoscopy/sigmoidoscopy component.
• not taking more than 4.8 grams/day of Asacol, greater than or equal to 6.75 grams/day of Colazal,or 2.4 grams/day of mesalamine or equivalent daily dose using any other 5-ASA products at any time during the 14 days preceding the initiation of study medication.
• if of childbearing potential, negative serum pregnancy test.

You may not qualify if:

• subject has a significant medical, including psychiatric, condition which in the opinion of the investigator precludes participation in the study.
• subject has a history of allergy or intolerance to aspirin, mesalamine, or other salicylates.
• subject's UC has worsened or failed to improve during chronic (i.e., at least 7) therapy with greater than or equal to 6.6 g/day days of balsalazide disodium within 30 days of screening
• subject has received chronic (i.e., greater than 15 consecutive days) of immunosuppressive therapy (e.g. azathioprine, 6 mercaptopurine) or corticosteroids within 30 days of screening. Intermittent use of oral or rectal immunosuppressive therapy or corticosteroids within 30 days of screening is permitted. Intravenous use of corticosteroids within 30 days of screening is not permitted.
• subject has received intra-rectal aminosalicylates for greater than 2 consecutive days within 7 days of screening.
• subject has had any prior bowel surgery, except appendectomy or cholecystectomy.
• subject has participated in an investigational drug or device study within the 30 days prior to study.
• subject is pregnant or at risk of pregnancy, or is lactating (female subjects only).
• subject shows evidence of current excessive alcohol consumption or drug dependence.
• subject has a history of human immunodeficiency virus (HIV). Subjects with history of hepatitis B and C will be eligible provided the screening LFTs are within normal limits.
• subject has other infectious, ischemic, or immunologic diseases with GI involvement.
• subject has twice the upper limit of normal (ULN) for any of the following LFTs: alanine aminotransferase (ALT/SGPT), aspartate aminotransferase (AST/SGOT), alkaline phosphatase, or total bilirubin (except isolated elevation of unconjugated bilirubin).
• subject has uncontrolled, clinically significant renal disease manifested by 1.5 × ULN of serum creatinine.
• subject has calculated creatinine clearance level of less than or equal to 60 mL/min.
• subject has unstable cardiovascular, coagulopathy or pulmonary disease characterized by a worsening in the disease condition that required a change in treatment or medical care within one (1) month of randomization.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (88)

Premiere Pharmaceutical Research

Tempe, Arizona, 85282, United States

Location

Arizona Clinical Research Center

Tucson, Arizona, 85715, United States

Location

Medical Services of Northwest Arkansas

Fayetteville, Arkansas, 72703, United States

Location

Gastroenterology Associates

Little Rock, Arkansas, 72205, United States

Location

AGMG Clinical Research Institute

Anaheim, California, 92801, United States

Location

West Gastroenterology Medical Group

Los Angeles, California, 90045, United States

Location

Sharp Rees-Stealy Medical Group

San Diego, California, 92101, United States

Location

Rocky Mountain Gastroenterology

Lakewood, Colorado, 80215, United States

Location

Arapahoe Gastroenterology, PC

Littleton, Colorado, 80120, United States

Location

South Denver Gastroenterology

Lone Tree, Colorado, 80124, United States

Location

Phoenix Internal Medical Associates

Waterbury, Connecticut, 06708, United States

Location

Clinical Trials Management of Bocal Raton

Boca Raton, Florida, 33486, United States

Location

Research Consultants Group

Hialeah, Florida, 33016, United States

Location

Horizon Institute for Clinical Researcg

Hollywood, Florida, 33021, United States

Location

Mark Lamet, M.D.

Hollywood, Florida, 33021, United States

Location

Borland-Grover Clinic

Jacksonville, Florida, 32256, United States

Location

A+ Research

Miami, Florida, 33155, United States

Location

West Wind'r Research & Development

Tampa, Florida, 33607, United States

Location

Shafran Gastroenterology Center

Winter Park, Florida, 32789, United States

Location

Florida Medical Clinic

Zephyrhills, Florida, 33542, United States

Location

The Atlanta Center for Gastroenterology

Atlanta, Georgia, 30033, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Atlanta Academic Research

Decatur, Georgia, 30033, United States

Location

Gastroenterology Associates of Central Georgia

Macon, Georgia, 31201, United States

Location

Digestive Research Associates

Newnan, Georgia, 30263, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 80120, United States

Location

Carle Clinic Association

Urbana, Illinois, 61801, United States

Location

Community Clinical Research Center

Anderson, Indiana, 46011, United States

Location

Iowa Digestive Disease Center

Clive, Iowa, 50325, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Clinical Trials Management

Metairie, Louisiana, 70006, United States

Location

Digestive Disorders Association

Annapolis, Maryland, 21401, United States

Location

Maryland Clinical Trials

Annapolis, Maryland, 21401, United States

Location

Alan Rosen, M.D.

Baltimore, Maryland, 21215, United States

Location

Digestive Disease Associates

Baltimore, Maryland, 21229, United States

Location

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

The Center for Clinical Research

Hagerstown, Maryland, 21740, United States

Location

Charm City Research

Lutherville, Maryland, 21093, United States

Location

Coastal Research Associates

Braintree, Massachusetts, 02184, United States

Location

Gastroenterology Associates of Western Michigan

Grand Rapids, Michigan, 49506, United States

Location

Borgess Research Institute

Kalamazoo, Michigan, 49048, United States

Location

Henry Ford West Bloomfield

West Bloomfield, Michigan, 48322, United States

Location

Gastrointestinal Associates

Jackson, Mississippi, 39202, United States

Location

Center for Digestive and Liver Diseases

Mexico, Missouri, 65265, United States

Location

The GI Group of South Jersey

Vineland, New Jersey, 08360, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Long Island Clinical

Great Neck, New York, 11021, United States

Location

New York Center for Clinical Research

Lake Success, New York, 11042, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Reseach Associates of NY

New York, New York, 10021, United States

Location

Simon Lichtiger, M.D.

New York, New York, 10128, United States

Location

Asheville Gastroenterology

Asheville, North Carolina, 28801, United States

Location

Charlotte Gastroenterology & Hematology, PLLC

Charlotte, North Carolina, 28207, United States

Location

Carolina Digestive Health Associates

Charlotte, North Carolina, 28211, United States

Location

Northwest Piedmont Clinical Research

Elkin, North Carolina, 28621, United States

Location

Carolina Research Center

Greenville, North Carolina, 27834, United States

Location

East Carolina Gastroenterology

Jacksonville, North Carolina, 28546, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Hanover Medical Specialists, PA

Wilmington, North Carolina, 28401, United States

Location

Wilmington Gastroenterology Associates

Wilmington, North Carolina, 28403, United States

Location

Digestive Health Specialists

Winston-Salem, North Carolina, 27103, United States

Location

Gastroenterology Specialists Inc.

Canton, Ohio, 44718, United States

Location

Digestive Health Network

Cincinnati, Ohio, 45220, United States

Location

Gastrointestinal & Liver Diseases Consultants, PC

Dayton, Ohio, 45440, United States

Location

AvamarCenter for Endoscopy

Warren, Ohio, 44484, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

Gastroenterology United of Tulsa

Tulsa, Oklahoma, 74135, United States

Location

West Hills Gastroenterology

Portland, Oregon, 97225, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Guthrie

Sayre, Pennsylvania, 18840, United States

Location

Charleston Gastroenterology Center

Charleston, South Carolina, 29414, United States

Location

MUSC Digestive Disease Center

Charleston, South Carolina, 29425, United States

Location

Clin Search

Chattanooga, Tennessee, 37404, United States

Location

ACE Research Specialists

Hermitage, Tennessee, 37067, United States

Location

Gastrointestinal Instititute PLLC

Nashville, Tennessee, 37203, United States

Location

Nashville Medical Research Institute

Nashville, Tennessee, 37205, United States

Location

Austin Gastroenterology

Austin, Texas, 78745, United States

Location

Houston Digestive Diseases Clinci

Houston, Texas, 77090, United States

Location

Houston Medical Research Associates

Houston, Texas, 77090, United States

Location

North Texas Gastroenterology

Lewisville, Texas, 75057, United States

Location

Gastroenterology Clinic of San Antonio

San Antonio, Texas, 78229, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

Liver and Digestive Disease Specialists

Norfolk, Virginia, 23502, United States

Location

McGuire VAMC

Richmond, Virginia, 23249, United States

Location

Discovery Research International

Milwaukee, Wisconsin, 53215, United States

Location

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Interventions

balsalazide

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 4, 2006
• First Posted: December 6, 2006
• Study Start: May 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: November 1, 2007
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

US (88)