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Ulcerative ColitisPhase 3NCT00269438

New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis

A Phase 3 study testing 5 ASA, enemas, suppositories, corticosteroids in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 66 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is 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 8 weeks of therapy. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Ulcerative Colitis
What is being tested?
5 ASA, enemas, suppositories, corticosteroids
How many people
225 participants
Where
66 sitesUnited States
Study dates
Dec 2005to Jun 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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A subject will be eligible for inclusion in this study only if all of the following criteria apply:
  • An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
  • Subject is a male or, if the subject is female, she is eligible to enter if she is of:
  • Non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who has undergone sterilization [hysterectomy or bilateral tubal ligation] or is post-menopausal. For purposes of this study, postmenopausal is defined as 1 year without menses);
  • OR,
  • Childbearing potential, has a negative serum pregnancy test at screen and, if heterosexually active, agrees to one of the following:
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  • Double barrier method of contraception, specifically, use of a condom and spermicide, for 1 week prior to study drug administration, throughout the 8 week Treatment Phase.
  • Oral contraceptives administered for at least 2 monthly cycles prior to study drug administration during all 6 months of study drug administration and administered for 1 monthly cycle following completion of the study.
  • An intrauterine device (IUD), inserted by a qualified clinician, with published data showing that the lowest expected failure rate is less than or equal to 1% per year (not all IUDs meet this criterion).
  • Medroxyprogesterone acetate (DEPO-PROVERA) administered for a minimum of 1 monthly cycle prior to the study drug administration, during all 6 months of study drug administration, and administered for 1 monthly cycle following study completion. Norelgestromin/ ethinyl estradiol transdermal system (Ortho Evra patch) administered for at least 2 monthly cycles prior to study drug administration and administered for 2 monthly cycles following study completion
  • Partner has undergone vasectomy and subject is in a monogamous relationship. The investigator is responsible for determining whether the subject is using appropriate birth control for study participation.
  • Subject is greater than or equal to 18 years of age.
  • Subjects with mildly to moderately active ulcerative colitis experiencing symptoms of an acute flare within the past 4 weeks.
  • Subject has not taken more than 2.4 grams of mesalamine or equivalent for a continuous period of 4 weeks preceding the screening visit
  • Subjects must have a baseline Modified Mayo Disease Activity Index (MMDAI) score between 6 and 10, inclusive. Additionally, subjects must score greater than or equal to 2 on Bleeding and greater than or equal to 2 on Endoscopy/Sigmoidoscopy.
  • Subject is capable and willing to comply with all study procedures.
  • Disease extends at least 20 cm from the rectum on screening sigmoidoscopy.

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply (Note: Development of any of the following exclusion criteria on-study will be considered a basis for subject discontinuation.):
  • 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 has recently (within the past 30 days) failed therapy with balsalazide disodium
  • Subject has received immunosuppressive therapy (e.g. azothioprine, 6 mercaptopurine) within 30 days, or corticosteroids (oral, intravenous [IV] or topical rectal) within 30 days prior to screening.
  • Subject has received intra-rectal aminosalicylates within 14 days of screening.
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  • Subject has had any prior bowel surgery, excepting appendectomy.
  • Subject has participated in an investigational drug or device study within the 30 days prior to study screening, with the exception of Salix protocols 3003 \& 3004 entitled: "A multicenter, randomized, double-blind, placebo controlled trial to evaluate the use of mesalamine pellet formulation 1.5G QD to maintain remission from mildly to moderate ulcerative colitis."
  • 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) or hepatitis (B and C).
  • 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 or blood urea nitrogen (BUN) levels.
  • Subject has calculated creatinine clearance level of less than or equal to 60 mL/min.
  • Subject has unstable cardiovascular, coagulopathy or pulmonary disease.
  • 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 and 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.
  • Females of Reproductive Potential:
  • If a female subject becomes pregnant while on this study, the study drug will be discontinued immediately and the subject followed until the outcome of the pregnancy is known. If a pregnancy occurs, it will be reported in the same manner as an unexpected AE using the guidelines provided in Section 6.4.1.9.
  • Premature Subject Discontinuation:
  • A subject may be discontinued from the study for the following medical or administrative reasons:
  • Occurrence of an AE, which in the judgment of the investigator suggests an unacceptable risk to the subject (The investigator will follow the subject until satisfactory resolution of the AE or the AE is determined to be stable);
  • Development on-study of any condition which, in the opinion of the investigator or the study sponsor, places the subject at an unacceptable medical risk if he/she continues;
  • Pregnancy;
  • Subject request;
  • Institution of additional medical (rescue) therapy for UC. The investigator may discontinue individual subjects from the study at any time. Subjects will be encouraged to complete the study; however they may voluntarily withdraw at any time. The investigator must provide written documentation of the reason for discontinuation on the CRF. Regardless of the reason for withdrawal, all subjects will be asked to undergo an end of therapy evaluation. Every attempt will be made to obtain all the end of study assessments, including all of the subscales of the MMDAI (i.e., bowel frequency, bleeding, physician's assessment, and endoscopy/sigmoidoscopy score).
  • Subjects who withdraw or are withdrawn will not be replaced under this protocol.

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

United States66 sites

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • Northwest Gastroenterologists S.C.

    Arlington Heights, Illinois, 60005

  • Gary Richter, M.D.

    Atlanta, Georgia, 30308

  • Woodholme Gastroenterology Associates, PA

    Baltimore, Maryland, 21208

  • Sinai Medical Office Building

    Baltimore, Maryland, 21215

  • Digestive Health Center of Louisiana

    Baton Rouge, Louisiana, 70809

  • Lovelace Scientific Resources

    Beverly Hills, California, 90211

  • Birmingham Gastroenterology Associates

    Birmingham, Alabama, 35209

  • Connecticut Gastroenterology Institute

    Bristol, Connecticut, 06010

  • Charleston Gastroenterology Specialists, LLC

    Charleston, South Carolina, 29414

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Consultants for Clinical Research, Inc.

    Cincinnati, Ohio, 45219

  • The Atlanta Center for Gastroenterology

    Decatur, Georgia, 30033

  • Central Jersey Primary Care Inc.

    Elizabeth, New Jersey, 07202

  • Digestive Liver Disease Specialists, Medical Group

    Garden Grove, California, 92840

  • LeBauer Research Associates, PA

    Greensboro, North Carolina, 27265

  • Medical Research Unlimited

    Hialeah, Florida, 33013

  • Bethany Medical Center

    High Point, North Carolina, 27262

  • Mark Lamet, M.D.

    Hollywood, Florida, 33021

  • Southern Clinical Research Consultants

    Hollywood, Florida, 33021

  • Mid Atlantic Medical Research Centers

    Hollywood, Maryland, 20636

  • Clinical Trial Network

    Houston, Texas, 77030

  • NationsMed Clinical Research

    Houston, Texas, 77034

  • Houston Digestive Disease Clinic

    Houston, Texas, 77090

  • Study site

    Kansas City, Missouri, 67131

  • Gastroenterology Associates

    Kingsport, Tennessee, 37660

  • Gastrointestinal Associates

    Knoxville, Tennessee, 37909

  • Therapeutic Research Institute of Orange County

    Laguna Hills, California, 92653

  • Little Rock Diagnostic Clinic

    Little Rock, Arkansas, 72205

  • Long Beach VA Medical Center

    Long Beach, California, 90822

  • University of Louisville

    Louisville, Kentucky, 40202

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31201

  • Memphis Gastroenterology Group

    Memphis, Tennessee, 38210

  • Center for Digestive & Liver Diseases

    Mexico, Missouri, 65265

  • Facey Medical Group

    Mission Hills, California, 91345

  • Spring Memorial Hospital

    Mobile, Alabama, 36608

  • Nashville Medical Research Institute

    Nashville, Tennessee, 37205

  • United Medical Research

    New Smyrna Beach, Florida, 32168

  • Study site

    New York, New York, 10128

  • Venture Research Institute, LLC

    North Miami Beach, Florida, 33162

  • University Digestive Health Center

    Oak Forest, Illinois, 60452

  • Study site

    Ocean City, New Jersey, 07712

  • Community Clinical Trials

    Orange, California, 92868

  • Advanced Gastroenterology Associates

    Palm Harbor, Florida, 34684

  • Boice-Willis Clinic

    Rocky Mount, North Carolina, 27804

  • Rider Research Group

    San Francisco, California, 94117

  • John Jolley, M.D.

    San Rafael, California, 94901

  • Lovelace Scientific Resources

    Santa Ana, California, 92704

  • Santa Barbara Clinical Research

    Santa Barbara, California, 93108

  • Lovelace Scientific Resources

    Sarasota, Florida, 34233

  • Advent Clinical Research

    Sarasota, Florida, 34239

  • Seattle Gastroenterology Associates

    Seattle, Washington, 98133

  • Hillcrest Clinical Research LLC

    Simpsonville, South Carolina, 29681

  • Eastern Washington Clinical Research Center

    Spokane, Washington, 99204

  • Spokane Digestive Disease Center Research

    Spokane, Washington, 99204

  • Clinical Research of Tampa Bay, Inc.

    Spring Hill, Florida, 34609

  • St. Louis Center for Clinical Research

    St Louis, Missouri, 63128

  • Stamford Therapeutic Consortium

    Stamford, Connecticut, 06905

  • VA Medical Center

    Syracuse, New York, 13210

  • Tacoma Digestive Disease Research Center

    Tacoma, Washington, 98405

  • Digestive Health Center

    Topeka, Kansas, 66606

  • Upstate Gastroenterology Associates, PC

    Troy, New York, 12180

  • Avamar Center for Gastroenterology, Inc.

    Warren, Ohio, 44484

  • Covenent Clinic

    Waterloo, Iowa, 50702

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: Phase 3 Study 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 8 Weeks of Therapy

The purpose of this study is 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 8 weeks of therapy.

Read the detailed description

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 eight weeks of therapy, where clinical improvement is defined as a greater than or equal to 3 point improvement from baseline in the MMDAI.

The secondary endpoints are as follows:

  1. The change from baseline over the duration of treatment in total MMDAI score and in the individual MMDAI subscales.
  2. The change from baseline to Weeks 1, 2, 4 and 8 in total MMDAI score and in each individual MMDAI subscale (endoscopy/sigmoidoscopy at Weeks 2 and 8 only).
  3. The proportion of subjects with treatment failure, defined as withdrawal due to significant disease progression or lack of significant improvement, as determined by the Investigator.
  4. The proportion of subjects with mucosal healing at Weeks 2 and 8, where mucosal healing is defined as an endoscopy/sigmoidoscopy score of 0 or 1
  5. The proportion of subjects achieving complete remission at Week 2 and Week 8, where complete remission is defined as a MMDAI score of less than or equal to 1.
  6. The proportion of subjects with improvement from baseline to Weeks 1, 2, 4 and 8 in total MMDAI score and in each individual MMDAI subscale (endoscopy/sigmoidoscopy at Weeks 2 and 8 only).
  7. Change from baseline to Weeks 1, 2, 4 and 8 in diarrhea, abdominal discomfort, and subjective sense of well being, as recorded in the subjects' diaries.
  8. The proportion of subjects achieving clinical remission at Weeks 1, 2, 4 and 8, where clinical remission is defined as a score of 0 for rectal bleeding and a combined score of less than or equal to 2 for bowel frequency and physician assessment using the MMDAI.
  9. Time to clinical remission, where clinical remission is defined as in secondary endpoint number eight.

Safety endpoints are as follows:

  • incidence of treatment-emergent AEs grouped by body system and evaluated by treatment group;
  • changes from baseline in clinical laboratory parameters at each treatment visit by treatment group; and
  • changes from baseline in vital sign measurements at each treatment visit by treatment group.
Being tested
5 ASA, enemas, suppositories, corticosteroids
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • 5 ASA, enemas, suppositories, corticosteroidsDrug

What is being measured

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

  1. Proportion of subjects that achieve clinical improvement and improvement in the rectal bleeding subscale of the MMDAI at the end of eight weeks of therapy, where clinical improvement is defined as a >3 point improvement from baseline in the MMDAI.

Secondary outcomes (1)

  1. The change from baseline over the duration of treatment in total MMDAI score and in the individual MMDAI subscales.

Timeline

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

  1. First posted23 Dec 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionMar 2007
  4. Study completionJun 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
Single group
Masking
Double blind
Enrolment
225 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00269438
Sponsor's protocol ID
BZUC3002
Status last verified
Nov 2019
First submitted
22 Dec 2005
Last updated
25 Nov 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5 ASA, enemas, suppositories, corticosteroids in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 66 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 17 inclusion and 35 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 66 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?

Proportion of subjects that achieve clinical improvement and improvement in the rectal bleeding subscale of the MMDAI at the end of eight weeks of therapy, where clinical improvement is defined as a >3 point improvement from baseline in the MMDAI.. 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 NCT00269438.

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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