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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2019
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


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.
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