New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
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
1 other identifier
interventional
225
1 country
66
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2005
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedNovember 25, 2019
November 1, 2019
1.2 years
December 22, 2005
November 21, 2019
Conditions
Outcome Measures
Primary Outcomes (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)
The change from baseline over the duration of treatment in total MMDAI score and in the individual MMDAI subscales.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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 Ă— 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.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Birmingham Gastroenterology Associates
Birmingham, Alabama, 35209, United States
Spring Memorial Hospital
Mobile, Alabama, 36608, United States
Little Rock Diagnostic Clinic
Little Rock, Arkansas, 72205, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Lovelace Scientific Resources
Beverly Hills, California, 90211, United States
Digestive Liver Disease Specialists, Medical Group
Garden Grove, California, 92840, United States
Therapeutic Research Institute of Orange County
Laguna Hills, California, 92653, United States
Long Beach VA Medical Center
Long Beach, California, 90822, United States
Facey Medical Group
Mission Hills, California, 91345, United States
Community Clinical Trials
Orange, California, 92868, United States
Rider Research Group
San Francisco, California, 94117, United States
John Jolley, M.D.
San Rafael, California, 94901, United States
Lovelace Scientific Resources
Santa Ana, California, 92704, United States
Santa Barbara Clinical Research
Santa Barbara, California, 93108, United States
Connecticut Gastroenterology Institute
Bristol, Connecticut, 06010, United States
Stamford Therapeutic Consortium
Stamford, Connecticut, 06905, United States
Medical Research Unlimited
Hialeah, Florida, 33013, United States
Mark Lamet, M.D.
Hollywood, Florida, 33021, United States
Southern Clinical Research Consultants
Hollywood, Florida, 33021, United States
United Medical Research
New Smyrna Beach, Florida, 32168, United States
Venture Research Institute, LLC
North Miami Beach, Florida, 33162, United States
Advanced Gastroenterology Associates
Palm Harbor, Florida, 34684, United States
Lovelace Scientific Resources
Sarasota, Florida, 34233, United States
Advent Clinical Research
Sarasota, Florida, 34239, United States
Clinical Research of Tampa Bay, Inc.
Spring Hill, Florida, 34609, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Gary Richter, M.D.
Atlanta, Georgia, 30308, United States
The Atlanta Center for Gastroenterology
Decatur, Georgia, 30033, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201, United States
Northwest Gastroenterologists S.C.
Arlington Heights, Illinois, 60005, United States
University Digestive Health Center
Oak Forest, Illinois, 60452, United States
Covenent Clinic
Waterloo, Iowa, 50702, United States
Digestive Health Center
Topeka, Kansas, 66606, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Digestive Health Center of Louisiana
Baton Rouge, Louisiana, 70809, United States
Woodholme Gastroenterology Associates, PA
Baltimore, Maryland, 21208, United States
Sinai Medical Office Building
Baltimore, Maryland, 21215, United States
Mid Atlantic Medical Research Centers
Hollywood, Maryland, 20636, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Unknown Facility
Kansas City, Missouri, 67131, United States
Center for Digestive & Liver Diseases
Mexico, Missouri, 65265, United States
St. Louis Center for Clinical Research
St Louis, Missouri, 63128, United States
Central Jersey Primary Care Inc.
Elizabeth, New Jersey, 07202, United States
Unknown Facility
Ocean City, New Jersey, 07712, United States
Unknown Facility
New York, New York, 10128, United States
VA Medical Center
Syracuse, New York, 13210, United States
Upstate Gastroenterology Associates, PC
Troy, New York, 12180, United States
LeBauer Research Associates, PA
Greensboro, North Carolina, 27265, United States
Bethany Medical Center
High Point, North Carolina, 27262, United States
Boice-Willis Clinic
Rocky Mount, North Carolina, 27804, United States
Consultants for Clinical Research, Inc.
Cincinnati, Ohio, 45219, United States
Avamar Center for Gastroenterology, Inc.
Warren, Ohio, 44484, United States
Charleston Gastroenterology Specialists, LLC
Charleston, South Carolina, 29414, United States
Hillcrest Clinical Research LLC
Simpsonville, South Carolina, 29681, United States
Gastroenterology Associates
Kingsport, Tennessee, 37660, United States
Gastrointestinal Associates
Knoxville, Tennessee, 37909, United States
Memphis Gastroenterology Group
Memphis, Tennessee, 38210, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Clinical Trial Network
Houston, Texas, 77030, United States
NationsMed Clinical Research
Houston, Texas, 77034, United States
Houston Digestive Disease Clinic
Houston, Texas, 77090, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Seattle Gastroenterology Associates
Seattle, Washington, 98133, United States
Eastern Washington Clinical Research Center
Spokane, Washington, 99204, United States
Spokane Digestive Disease Center Research
Spokane, Washington, 99204, United States
Tacoma Digestive Disease Research Center
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 23, 2005
Study Start
December 1, 2005
Primary Completion
March 1, 2007
Study Completion
June 1, 2007
Last Updated
November 25, 2019
Record last verified: 2019-11