Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis
- Conditions
- Inflammatory Bowel DiseaseUlcerative Colitis
- Registration Number
- NCT00408174
- Lead Sponsor
- Bausch Health Americas, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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.
- 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.
- subject has active malignancy within the last 5 years, except basal cell carcinoma of the skin, or if female, in situ cervical carcinoma that has been surgically excised.
- subject has any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.
- subject has sclerosing cholangitis.
- subject has positive stool culture for ovum and parasites (O&P) or C. difficile.
- subject has been treated with infliximab, cyclosporine, natalizumab, or methotrexate for ulcerative colitis within the last 30 days prior to screening.
- regular use of NSAIDS except cardioprotective ASA (i.e., less than or equal to 162 mg ASA per day).
- subject has received cell-depleting therapies such as the Adacolumn.
- subject requires antidiarrheal therapy during screening.
- subject has clinical or radiographic findings suggestive of serious UC complications such as toxic megacolon or colonic perforation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (88)
West Gastroenterology Medical Group
🇺🇸Los Angeles, California, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
The Center for Clinical Research
🇺🇸Hagerstown, Maryland, United States
AGMG Clinical Research Institute
🇺🇸Anaheim, California, United States
Horizon Institute for Clinical Researcg
🇺🇸Hollywood, Florida, United States
Borland-Grover Clinic
🇺🇸Jacksonville, Florida, United States
Medical Services of Northwest Arkansas
🇺🇸Fayetteville, Arkansas, United States
Community Clinical Research Center
🇺🇸Anderson, Indiana, United States
Research Consultants Group
🇺🇸Hialeah, Florida, United States
Carle Clinic Association
🇺🇸Urbana, Illinois, United States
Carolina Digestive Health Associates
🇺🇸Charlotte, North Carolina, United States
Maryland Clinical Trials
🇺🇸Annapolis, Maryland, United States
Clinical Trials Management of Bocal Raton
🇺🇸Boca Raton, Florida, United States
Henry Ford West Bloomfield
🇺🇸West Bloomfield, Michigan, United States
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
The Atlanta Center for Gastroenterology
🇺🇸Atlanta, Georgia, United States
Phoenix Internal Medical Associates
🇺🇸Waterbury, Connecticut, United States
Gastroenterology Associates
🇺🇸Little Rock, Arkansas, United States
Florida Medical Clinic
🇺🇸Zephyrhills, Florida, United States
Rocky Mountain Gastroenterology
🇺🇸Lakewood, Colorado, United States
Charm City Research
🇺🇸Lutherville, Maryland, United States
Clinical Trials Management
🇺🇸Metairie, Louisiana, United States
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Guthrie
🇺🇸Sayre, Pennsylvania, United States
Gastroenterology Associates of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
The GI Group of South Jersey
🇺🇸Vineland, New Jersey, United States
Atlanta Academic Research
🇺🇸Decatur, Georgia, United States
Digestive Disorders Association
🇺🇸Annapolis, Maryland, United States
Digestive Disease Associates
🇺🇸Baltimore, Maryland, United States
Charlotte Gastroenterology & Hematology, PLLC
🇺🇸Charlotte, North Carolina, United States
Borgess Research Institute
🇺🇸Kalamazoo, Michigan, United States
Coastal Research Associates
🇺🇸Braintree, Massachusetts, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Simon Lichtiger, M.D.
🇺🇸New York, New York, United States
Long Island Clinical
🇺🇸Great Neck, New York, United States
East Carolina Gastroenterology
🇺🇸Jacksonville, North Carolina, United States
AvamarCenter for Endoscopy
🇺🇸Warren, Ohio, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Houston Digestive Diseases Clinci
🇺🇸Houston, Texas, United States
Houston Medical Research Associates
🇺🇸Houston, Texas, United States
Sharp Rees-Stealy Medical Group
🇺🇸San Diego, California, United States
A+ Research
🇺🇸Miami, Florida, United States
Nashville Medical Research Institute
🇺🇸Nashville, Tennessee, United States
Gastroenterology Clinic of San Antonio
🇺🇸San Antonio, Texas, United States
Digestive Health Network
🇺🇸Cincinnati, Ohio, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Gastrointestinal Instititute PLLC
🇺🇸Nashville, Tennessee, United States
West Hills Gastroenterology
🇺🇸Portland, Oregon, United States
Discovery Research International
🇺🇸Milwaukee, Wisconsin, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
South Denver Gastroenterology
🇺🇸Lone Tree, Colorado, United States
Northwest Piedmont Clinical Research
🇺🇸Elkin, North Carolina, United States
Wilmington Gastroenterology Associates
🇺🇸Wilmington, North Carolina, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Premiere Pharmaceutical Research
🇺🇸Tempe, Arizona, United States
Arapahoe Gastroenterology, PC
🇺🇸Littleton, Colorado, United States
Mark Lamet, M.D.
🇺🇸Hollywood, Florida, United States
Digestive Research Associates
🇺🇸Newnan, Georgia, United States
Iowa Digestive Disease Center
🇺🇸Clive, Iowa, United States
Alan Rosen, M.D.
🇺🇸Baltimore, Maryland, United States
Center for Digestive and Liver Diseases
🇺🇸Mexico, Missouri, United States
New York Center for Clinical Research
🇺🇸Lake Success, New York, United States
Reseach Associates of NY
🇺🇸New York, New York, United States
Carolina Research Center
🇺🇸Greenville, North Carolina, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Hanover Medical Specialists, PA
🇺🇸Wilmington, North Carolina, United States
Gastroenterology Specialists Inc.
🇺🇸Canton, Ohio, United States
Gastrointestinal & Liver Diseases Consultants, PC
🇺🇸Dayton, Ohio, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
North Texas Gastroenterology
🇺🇸Lewisville, Texas, United States
ACE Research Specialists
🇺🇸Hermitage, Tennessee, United States
Liver and Digestive Disease Specialists
🇺🇸Norfolk, Virginia, United States
Gastroenterology Associates of Central Georgia
🇺🇸Macon, Georgia, United States
Gastroenterology United of Tulsa
🇺🇸Tulsa, Oklahoma, United States
Clin Search
🇺🇸Chattanooga, Tennessee, United States
Gastroenterology Associates of Tidewater
🇺🇸Chesapeake, Virginia, United States
Gastrointestinal Associates
🇺🇸Jackson, Mississippi, United States
Asheville Gastroenterology
🇺🇸Asheville, North Carolina, United States
West Wind'r Research & Development
🇺🇸Tampa, Florida, United States
Charleston Gastroenterology Center
🇺🇸Charleston, South Carolina, United States
Digestive Health Specialists
🇺🇸Winston-Salem, North Carolina, United States
MUSC Digestive Disease Center
🇺🇸Charleston, South Carolina, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Austin Gastroenterology
🇺🇸Austin, Texas, United States
McGuire VAMC
🇺🇸Richmond, Virginia, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States