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Inflammatory Bowel DiseasePhase 3NCT00408174

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

A Phase 3 study testing Balsalazide disodium in people with Inflammatory Bowel Disease and Ulcerative Colitis, run by Bausch Health Americas, Inc. at 88 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Balsalazide disodium
How many people
400 participants
Where
88 sitesUnited States
Study dates
May 2006to Nov 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.

Trial locations and contacts

88 sites in 1 country.

88 sites in 1 country

United States88 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • AGMG Clinical Research Institute

    Anaheim, California, 92801

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • Digestive Disorders Association

    Annapolis, Maryland, 21401

  • Maryland Clinical Trials

    Annapolis, Maryland, 21401

  • Asheville Gastroenterology

    Asheville, North Carolina, 28801

  • The Atlanta Center for Gastroenterology

    Atlanta, Georgia, 30033

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Austin Gastroenterology

    Austin, Texas, 78745

  • Alan Rosen, M.D.

    Baltimore, Maryland, 21215

  • Digestive Disease Associates

    Baltimore, Maryland, 21229

  • Clinical Trials Management of Bocal Raton

    Boca Raton, Florida, 33486

  • Coastal Research Associates

    Braintree, Massachusetts, 02184

  • Gastroenterology Specialists Inc.

    Canton, Ohio, 44718

  • Charleston Gastroenterology Center

    Charleston, South Carolina, 29414

  • MUSC Digestive Disease Center

    Charleston, South Carolina, 29425

  • Charlotte Gastroenterology & Hematology, PLLC

    Charlotte, North Carolina, 28207

  • Carolina Digestive Health Associates

    Charlotte, North Carolina, 28211

  • Clin Search

    Chattanooga, Tennessee, 37404

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • University of Illinois at Chicago

    Chicago, Illinois, 80120

  • Digestive Health Network

    Cincinnati, Ohio, 45220

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Gastrointestinal & Liver Diseases Consultants, PC

    Dayton, Ohio, 45440

  • Atlanta Academic Research

    Decatur, Georgia, 30033

  • Northwest Piedmont Clinical Research

    Elkin, North Carolina, 28621

  • Medical Services of Northwest Arkansas

    Fayetteville, Arkansas, 72703

  • Gastroenterology Associates of Western Michigan

    Grand Rapids, Michigan, 49506

  • Long Island Clinical

    Great Neck, New York, 11021

  • Carolina Research Center

    Greenville, North Carolina, 27834

  • The Center for Clinical Research

    Hagerstown, Maryland, 21740

  • ACE Research Specialists

    Hermitage, Tennessee, 37067

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Research Consultants Group

    Hialeah, Florida, 33016

  • Horizon Institute for Clinical Researcg

    Hollywood, Florida, 33021

  • Mark Lamet, M.D.

    Hollywood, Florida, 33021

  • Houston Digestive Diseases Clinci

    Houston, Texas, 77090

  • Houston Medical Research Associates

    Houston, Texas, 77090

  • Gastrointestinal Associates

    Jackson, Mississippi, 39202

  • Borland-Grover Clinic

    Jacksonville, Florida, 32256

  • East Carolina Gastroenterology

    Jacksonville, North Carolina, 28546

  • Borgess Research Institute

    Kalamazoo, Michigan, 49048

  • New York Center for Clinical Research

    Lake Success, New York, 11042

  • Rocky Mountain Gastroenterology

    Lakewood, Colorado, 80215

  • North Texas Gastroenterology

    Lewisville, Texas, 75057

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • Gastroenterology Associates

    Little Rock, Arkansas, 72205

  • Arapahoe Gastroenterology, PC

    Littleton, Colorado, 80120

  • South Denver Gastroenterology

    Lone Tree, Colorado, 80124

  • West Gastroenterology Medical Group

    Los Angeles, California, 90045

  • Charm City Research

    Lutherville, Maryland, 21093

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31201

  • Clinical Trials Management

    Metairie, Louisiana, 70006

  • Center for Digestive and Liver Diseases

    Mexico, Missouri, 65265

  • A+ Research

    Miami, Florida, 33155

  • Discovery Research International

    Milwaukee, Wisconsin, 53215

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Gastrointestinal Instititute PLLC

    Nashville, Tennessee, 37203

  • Nashville Medical Research Institute

    Nashville, Tennessee, 37205

  • Reseach Associates of NY

    New York, New York, 10021

  • Simon Lichtiger, M.D.

    New York, New York, 10128

  • Digestive Research Associates

    Newnan, Georgia, 30263

  • Liver and Digestive Disease Specialists

    Norfolk, Virginia, 23502

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • West Hills Gastroenterology

    Portland, Oregon, 97225

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • McGuire VAMC

    Richmond, Virginia, 23249

  • Gastroenterology Clinic of San Antonio

    San Antonio, Texas, 78229

  • Sharp Rees-Stealy Medical Group

    San Diego, California, 92101

  • Guthrie

    Sayre, Pennsylvania, 18840

  • West Wind'r Research & Development

    Tampa, Florida, 33607

  • Premiere Pharmaceutical Research

    Tempe, Arizona, 85282

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715

  • Gastroenterology United of Tulsa

    Tulsa, Oklahoma, 74135

  • Carle Clinic Association

    Urbana, Illinois, 61801

  • The GI Group of South Jersey

    Vineland, New Jersey, 08360

  • AvamarCenter for Endoscopy

    Warren, Ohio, 44484

  • Phoenix Internal Medical Associates

    Waterbury, Connecticut, 06708

  • Henry Ford West Bloomfield

    West Bloomfield, Michigan, 48322

  • Hanover Medical Specialists, PA

    Wilmington, North Carolina, 28401

  • Wilmington Gastroenterology Associates

    Wilmington, North Carolina, 28403

  • Digestive Health Specialists

    Winston-Salem, North Carolina, 27103

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

  • Florida Medical Clinic

    Zephyrhills, Florida, 33542

Other trials in United States

About this study

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

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.

Being tested
Balsalazide disodium
Keywords
IBD, UC, Ulcerative Colitis, Inflammatory Bowel Disease
Medical subject headings
Inflammatory Bowel Diseases, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Balsalazide disodiumDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJul 2007
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00408174
Sponsor's protocol ID
BZUC3003
Status last verified
Nov 2019
First submitted
4 Dec 2006
Last updated
25 Nov 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Balsalazide disodium in people with Inflammatory Bowel Disease and Ulcerative Colitis, run by Bausch Health Americas, Inc. at 88 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00408174.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.

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