Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis

Completed · Phase 3

Conditions studied: Ulcerative Colitis

In brief

Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.

Key facts

Study ID

NCT00151892

Run by

Shire

People needed

829

Starts

2005-04-08

Expected to finish

2009-09-07

Last updated by the study team

2021-06-14

Who can join

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

You may qualify if…

• previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for => 30 days
• female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contraception

You may not qualify if…

• proctitis
• previous resective colonic surgery
• Crohn's disease
• hypersensitivity to salicylates
• moderate/severe renal impairment

Where it is running

• Connecticut Gastroenterology Institute — Bristol, Connecticut, United States
• Washington Gastroenterology — Washington D.C., District of Columbia, United States
• Southern Clinical Research Consultants — Hollywood, Florida, United States
• Boorland-Groover Clinic — Jacksonville, Florida, United States
• United Medical Research — New Smyrna Beach, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Midwest Clinical Research Center — Moline, Illinois, United States
• Gastrointestinal Clinic of Quad Cities — Davenport, Iowa, United States
• Drug Research Services, Inc. — Metairie, Louisiana, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Center for Digestive and Liver Diseases, Inc — Mexico, Missouri, United States
• New York Center for Clinical Research — Lake Success, New York, United States
• ClinSearch — Chattanooga, Tennessee, United States
• S D Khan — Houston, Texas, United States
• Hospital Italiano de Buenos Aires — Capital Federal, Buenos Aires, Argentina
• Centro Integral De Gastroenterologia — Ciudad de Buenos Aires, Argentina
• Hospital Italiano de Mendoza, FINAMED SA — Mendoza, Argentina
• Bankstown-Lidcombe Hospital — Bankstown, New South Wales, Australia
• Concord Hospital — Concord, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Eastern Health Hospital — Box Hill, Victoria, Australia
• St Vincent's Hospital — Fitzroy, Victoria, Australia
• Fremantle Hospital — Fremantle, Western Australia, Australia
• Imelda General Hospital — Bonheiden, Belgium
• Birmingham Gastroenterology Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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