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

Completed · Phase 3

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID: NCT00269438
Run by: Bausch Health Americas, Inc.
People needed: 225
Starts: 2005-12-01
Expected to finish: 2007-06-01
Last updated by the study team: 2019-11-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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:
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.

You may not qualify if…

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.
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.

Where it is running

Spring Memorial Hospital — Mobile, Alabama, United States
Little Rock Diagnostic Clinic — Little Rock, Arkansas, United States
Advanced Clinical Research Institute — Anaheim, California, United States
Lovelace Scientific Resources — Beverly Hills, California, United States
Digestive Liver Disease Specialists, Medical Group — Garden Grove, California, United States
Therapeutic Research Institute of Orange County — Laguna Hills, California, United States
Long Beach VA Medical Center — Long Beach, California, United States
Facey Medical Group — Mission Hills, California, United States
Community Clinical Trials — Orange, California, United States
Rider Research Group — San Francisco, California, United States
John Jolley, M.D. — San Rafael, California, United States
Lovelace Scientific Resources — Santa Ana, California, United States
Santa Barbara Clinical Research — Santa Barbara, California, United States
Connecticut Gastroenterology Institute — Bristol, Connecticut, United States
Stamford Therapeutic Consortium — Stamford, Connecticut, United States
Medical Research Unlimited — Hialeah, Florida, United States
Mark Lamet, M.D. — Hollywood, Florida, United States
Southern Clinical Research Consultants — Hollywood, Florida, United States
United Medical Research — New Smyrna Beach, Florida, United States
Venture Research Institute, LLC — North Miami Beach, Florida, United States
Advanced Gastroenterology Associates — Palm Harbor, Florida, United States
Lovelace Scientific Resources — Sarasota, Florida, United States
Advent Clinical Research — Sarasota, Florida, United States
Clinical Research of Tampa Bay, Inc. — Spring Hill, Florida, United States
Birmingham Gastroenterology Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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