Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study

Completed · Phase 3

Conditions studied: Inflammatory Bowel Disease, Ulcerative Colitis

In brief

The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.

Key facts

Study ID

NCT00486031

Run by

Bausch Health Americas, Inc.

People needed

443

Starts

2006-10-01

Expected to finish

2008-12-01

Last updated by the study team

2019-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has a documented history of UC and is either in remission or currently presents with mildly to moderately active UC symptoms as determined by the investigator upon subject interview of UC symptoms, (e.g., urgency, bowel frequency, and rectal bleeding). Additionally, the diagnosis of UC must be confirmed by past flexible sigmoidoscopy/colonoscopy which may include colonic mucosal pathological findings on biopsy consistent with UC.
• Subject is capable and willing to comply with all study procedures.

You may not qualify if…

• Subject has a history of allergy or intolerance to aspirin, mesalamine or other salicylates.
• Subject has participated in an investigational drug or device study, other than a previous balsalazide disodium tablet trial (i.e., BZUC3002 or BZUC3003), within 30 days of entering the current study.
• Subject discontinued from a previous balsalazide disodium tablet study due to study drug-related AE(s), including UC flare or associated symptoms that were perceived by the subject/investigator as being caused by study drug.
• Subject has had any prior bowel surgery, except appendectomy and cholecystectomy.
• Subject has unstable cardiovascular, coagulopathy, or pulmonary disease.
• Regular use of nonsteroidal anti-inflammatory drugs (NSAIDS) except cardioprotective ASA (i.e., less than or equal to 162 mg ASA per day).
• Subject has a history of human immunodeficiency virus (HIV) or hepatitis (B and C). Subjects with a history of hepatitis B and C will be eligible provided the screening LFTs are within normal limits.

Where it is running

• Premeire Pharmaceutical Research — Tempe, Arizona, United States
• Medical Services of NWA — Fayetteville, Arkansas, United States
• AGMG Clinical Research Institute — Anaheim, California, United States
• Discovery Clinical Research, Inc. — Encinitas, California, United States
• Digestive and Liver Disease Specialists — Garden Grove, California, United States
• West Gastroenterology Medical Group — Los Angeles, California, United States
• Community Clinical Trials — Orange, California, United States
• Sharp Rees-Stealy Medical — San Diego, California, United States
• Rocky Mountain Gastroenterology — Lakewood, Colorado, United States
• Arapahoe Gastrroenterology, PC — Littleton, Colorado, United States
• South Denver Gastroenterology — Lone Tree, Colorado, United States
• Connecticut Gastroenterology Institute — Bristol, Connecticut, United States
• Clinical Trials Management of Boca Raton — Boca Raton, Florida, United States
• Research Consultants Group — Hialeah, Florida, United States
• Horizon Institute for Clinical Research — Hollywood, Florida, United States
• Mark Lamet, M.D. — Hollywood, Florida, United States
• Southern Clinical Research Consultants — Hollywood, Florida, United States
• A+ Research — Miami, Florida, United States
• United Medical Research — New Smyrna Beach, Florida, United States
• Venture Research Institute, LLC — North Miami Beach, Florida, United States
• West Wind'r Research & Development — Tampa, Florida, United States
• Shafran Gastroenterology Center — Winter Park, Florida, United States
• Florida Medical Clinic, PA — Zephyrhills, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Birmingham Gastroenterology Associates, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.