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

November 21, 2019 updated by: Bausch Health Americas, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Balsalazide disodium

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Tempe, Arizona, United States, 85282
    - Premiere Pharmaceutical Research
  - Tucson, Arizona, United States, 85715
    - Arizona Clinical Research Center
- Arkansas
  - Fayetteville, Arkansas, United States, 72703
    - Medical Services of Northwest Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Gastroenterology Associates
- California
  - Anaheim, California, United States, 92801
    - AGMG Clinical Research Institute
  - Los Angeles, California, United States, 90045
    - West Gastroenterology Medical Group
  - San Diego, California, United States, 92101
    - Sharp Rees-Stealy Medical Group
- Colorado
  - Lakewood, Colorado, United States, 80215
    - Rocky Mountain Gastroenterology
  - Littleton, Colorado, United States, 80120
    - Arapahoe Gastroenterology, PC
  - Lone Tree, Colorado, United States, 80124
    - South Denver Gastroenterology
- Connecticut
  - Waterbury, Connecticut, United States, 06708
    - Phoenix Internal Medical Associates
- Florida
  - Boca Raton, Florida, United States, 33486
    - Clinical Trials Management of Bocal Raton
  - Hialeah, Florida, United States, 33016
    - Research Consultants Group
  - Hollywood, Florida, United States, 33021
    - Horizon Institute for Clinical Researcg
  - Hollywood, Florida, United States, 33021
    - Mark Lamet, M.D.
  - Jacksonville, Florida, United States, 32256
    - Borland-Grover Clinic
  - Miami, Florida, United States, 33155
    - A+ Research
  - Tampa, Florida, United States, 33607
    - West Wind'r Research & Development
  - Winter Park, Florida, United States, 32789
    - Shafran Gastroenterology Center
  - Zephyrhills, Florida, United States, 33542
    - Florida Medical Clinic
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Atlanta Gastroenterology Associates
  - Atlanta, Georgia, United States, 30033
    - The Atlanta Center For Gastroenterology
  - Decatur, Georgia, United States, 30033
    - Atlanta Academic Research
  - Macon, Georgia, United States, 31201
    - Gastroenterology Associates of Central Georgia
  - Newnan, Georgia, United States, 30263
    - Digestive Research Associates
- Illinois
  - Chicago, Illinois, United States, 80120
    - University of Illinois at Chicago
  - Urbana, Illinois, United States, 61801
    - Carle Clinic Association
- Indiana
  - Anderson, Indiana, United States, 46011
    - Community Clinical Research Center
- Iowa
  - Clive, Iowa, United States, 50325
    - Iowa Digestive Disease Center
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky Medical Center
- Louisiana
  - Metairie, Louisiana, United States, 70006
    - Clinical Trials Management
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Maryland Clinical Trials
  - Annapolis, Maryland, United States, 21401
    - Digestive Disorders Association
  - Baltimore, Maryland, United States, 21229
    - Digestive Disease Associates
  - Baltimore, Maryland, United States, 21215
    - Alan Rosen, M.D.
  - Chevy Chase, Maryland, United States, 20815
    - Chevy Chase Clinical Research
  - Hagerstown, Maryland, United States, 21740
    - The Center for Clinical Research
  - Lutherville, Maryland, United States, 21093
    - Charm City Research
- Massachusetts
  - Braintree, Massachusetts, United States, 02184
    - Coastal Research Associates
- Michigan
  - Grand Rapids, Michigan, United States, 49506
    - Gastroenterology Associates of Western Michigan
  - Kalamazoo, Michigan, United States, 49048
    - Borgess Research Institute
  - West Bloomfield, Michigan, United States, 48322
    - Henry Ford West Bloomfield
- Mississippi
  - Jackson, Mississippi, United States, 39202
    - Gastrointestinal Associates
- Missouri
  - Mexico, Missouri, United States, 65265
    - Center for Digestive and Liver Diseases
- New Jersey
  - Vineland, New Jersey, United States, 08360
    - The GI Group of South Jersey
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - University of New Mexico
- New York
  - Great Neck, New York, United States, 11021
    - Long Island Clinical
  - Lake Success, New York, United States, 11042
    - New York Center for Clinical Research
  - Mineola, New York, United States, 11501
    - Winthrop University Hospital
  - New York, New York, United States, 10128
    - Simon Lichtiger, M.D.
  - New York, New York, United States, 10021
    - Reseach Associates of NY
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Asheville Gastroenterology
  - Charlotte, North Carolina, United States, 28211
    - Carolina Digestive Health Associates
  - Charlotte, North Carolina, United States, 28207
    - Charlotte Gastroenterology & Hematology, PLLC
  - Elkin, North Carolina, United States, 28621
    - Northwest Piedmont Clinical Research
  - Greenville, North Carolina, United States, 27834
    - Carolina Research Center
  - Jacksonville, North Carolina, United States, 28546
    - East Carolina Gastroenterology
  - Raleigh, North Carolina, United States, 27612
    - Wake Research Associates, LLC
  - Wilmington, North Carolina, United States, 28401
    - Hanover Medical Specialists, PA
  - Wilmington, North Carolina, United States, 28403
    - Wilmington Gastroenterology Associates
  - Winston-Salem, North Carolina, United States, 27103
    - Digestive Health Specialists
- Ohio
  - Canton, Ohio, United States, 44718
    - Gastroenterology Specialists Inc.
  - Cincinnati, Ohio, United States, 45220
    - Digestive Health Network
  - Dayton, Ohio, United States, 45440
    - Gastrointestinal & Liver Diseases Consultants, PC
  - Warren, Ohio, United States, 44484
    - AvamarCenter for Endoscopy
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Sooner Clinical Research
  - Tulsa, Oklahoma, United States, 74135
    - Gastroenterology United of Tulsa
- Oregon
  - Portland, Oregon, United States, 97225
    - West Hills Gastroenterology
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Penn State Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, United States, 19107
    - Thomas Jefferson University
  - Sayre, Pennsylvania, United States, 18840
    - Guthrie
- South Carolina
  - Charleston, South Carolina, United States, 29414
    - Charleston Gastroenterology Center
  - Charleston, South Carolina, United States, 29425
    - MUSC Digestive Disease Center
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Clin Search
  - Hermitage, Tennessee, United States, 37067
    - Ace Research Specialists
  - Nashville, Tennessee, United States, 37205
    - Nashville Medical Research Institute
  - Nashville, Tennessee, United States, 37203
    - Gastrointestinal Instititute PLLC
- Texas
  - Austin, Texas, United States, 78745
    - Austin Gastroenterology
  - Houston, Texas, United States, 77090
    - Houston Medical Research Associates
  - Houston, Texas, United States, 77090
    - Houston Digestive Diseases Clinci
  - Lewisville, Texas, United States, 75057
    - North Texas Gastroenterology
  - San Antonio, Texas, United States, 78229
    - Gastroenterology Clinic of San Antonio
- Utah
  - Ogden, Utah, United States, 84405
    - Advanced Research Institute
- Virginia
  - Chesapeake, Virginia, United States, 23320
    - Gastroenterology Associates of Tidewater
  - Norfolk, Virginia, United States, 23502
    - Liver and Digestive Disease Specialists
  - Richmond, Virginia, United States, 23249
    - McGuire VAMC
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53215
    - Wisconsin Center for Advanced Research
  - Milwaukee, Wisconsin, United States, 53215
    - Discovery Research International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

December 4, 2006

First Submitted That Met QC Criteria

December 4, 2006

First Posted (Estimate)

December 6, 2006

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

BZUC3003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.