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
NCT number | NCT00408174 |
Other study ID # | BZUC3003 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 2006 |
Est. completion date | November 2007 |
Verified date | November 2019 |
Source | Bausch Health Americas, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Bausch Health Americas, Inc. |
United States,
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. |
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