Clinical trial NCT00408174: Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis
Official title: A Multicenter, Randomized, Double-Blind, Actively-Controlled Trial to Evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 g Bid Versus Mesalamine (5-ASA) as Asacol® 0.8 g Tid in Mildly to Moderately Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammatory Bowel Disease
Ulcerative Colitis
Keywords: IBD
UC
Ulcerative Colitis
Inflammatory Bowel Disease
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2006-12-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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 outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Premiere Pharmaceutical Research
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Fayetteville
country: United States
facility: Medical Services of Northwest Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: Gastroenterology Associates
state: Arkansas
city: Anaheim
country: United States
facility: AGMG Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: West Gastroenterology Medical Group
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: Lakewood
country: United States
facility: Rocky Mountain Gastroenterology
state: Colorado
city: Littleton
country: United States
facility: Arapahoe Gastroenterology, PC
state: Colorado
city: Lone Tree
country: United States
facility: South Denver Gastroenterology
state: Colorado
city: Waterbury
country: United States
facility: Phoenix Internal Medical Associates
state: Connecticut
city: Boca Raton
country: United States
facility: Clinical Trials Management of Bocal Raton
state: Florida
city: Hialeah
country: United States
facility: Research Consultants Group
state: Florida
city: Hollywood
country: United States
facility: Horizon Institute for Clinical Researcg
state: Florida
city: Hollywood
country: United States
facility: Mark Lamet, M.D.
state: Florida
city: Jacksonville
country: United States
facility: Borland-Grover Clinic
state: Florida
city: Miami
country: United States
facility: A+ Research
state: Florida
city: Tampa
country: United States
facility: West Wind'r Research & Development
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic
state: Florida
city: Atlanta
country: United States
facility: The Atlanta Center for Gastroenterology
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Decatur
country: United States
facility: Atlanta Academic Research
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Newnan
country: United States
facility: Digestive Research Associates
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Urbana
country: United States
facility: Carle Clinic Association
state: Illinois
city: Anderson
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Metairie
country: United States
facility: Clinical Trials Management
state: Louisiana
city: Annapolis
country: United States
facility: Digestive Disorders Association
state: Maryland
city: Annapolis
country: United States
facility: Maryland Clinical Trials
state: Maryland
city: Baltimore
country: United States
facility: Alan Rosen, M.D.
state: Maryland
city: Baltimore
country: United States
facility: Digestive Disease Associates
state: Maryland
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Hagerstown
country: United States
facility: The Center for Clinical Research
state: Maryland
city: Lutherville
country: United States
facility: Charm City Research
state: Maryland
city: Braintree
country: United States
facility: Coastal Research Associates
state: Massachusetts
city: Grand Rapids
country: United States
facility: Gastroenterology Associates of Western Michigan
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford West Bloomfield
state: Michigan
city: Jackson
country: United States
facility: Gastrointestinal Associates
state: Mississippi
city: Mexico
country: United States
facility: Center for Digestive and Liver Diseases
state: Missouri
city: Vineland
country: United States
facility: The GI Group of South Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Great Neck
country: United States
facility: Long Island Clinical
state: New York
city: Lake Success
country: United States
facility: New York Center for Clinical Research
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: Reseach Associates of NY
state: New York
city: New York
country: United States
facility: Simon Lichtiger, M.D.
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hematology, PLLC
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Elkin
country: United States
facility: Northwest Piedmont Clinical Research
state: North Carolina
city: Greenville
country: United States
facility: Carolina Research Center
state: North Carolina
city: Jacksonville
country: United States
facility: East Carolina Gastroenterology
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Hanover Medical Specialists, PA
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Gastroenterology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists
state: North Carolina
city: Canton
country: United States
facility: Gastroenterology Specialists Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Digestive Health Network
state: Ohio
city: Dayton
country: United States
facility: Gastrointestinal & Liver Diseases Consultants, PC
state: Ohio
city: Warren
country: United States
facility: AvamarCenter for Endoscopy
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Gastroenterology United of Tulsa
state: Oklahoma
city: Portland
country: United States
facility: West Hills Gastroenterology
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Gastroenterology Center
state: South Carolina
city: Charleston
country: United States
facility: MUSC Digestive Disease Center
state: South Carolina
city: Chattanooga
country: United States
facility: Clin Search
state: Tennessee
city: Hermitage
country: United States
facility: ACE Research Specialists
state: Tennessee
city: Nashville
country: United States
facility: Gastrointestinal Instititute PLLC
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Gastroenterology
state: Texas
city: Houston
country: United States
facility: Houston Digestive Diseases Clinci
state: Texas
city: Houston
country: United States
facility: Houston Medical Research Associates
state: Texas
city: Lewisville
country: United States
facility: North Texas Gastroenterology
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Clinic of San Antonio
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Norfolk
country: United States
facility: Liver and Digestive Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: McGuire VAMC
state: Virginia
city: Milwaukee
country: United States
facility: Discovery Research International
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
References: