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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408174
• Other study ID #: BZUC3003
• Status: Completed
• Phase: Phase 3
• Start date: May 2006
• Est. completion date: November 2007

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Balsalazide disodium

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.