Status:
COMPLETED
Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
Lead Sponsor:
Shire
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 d...
Eligibility Criteria
Inclusion
- 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
Exclusion
- proctitis
- previous resective colonic surgery
- Crohn's disease
- hypersensitivity to salicylates
- moderate/severe renal impairment
Key Trial Info
Start Date :
April 8 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2009
Estimated Enrollment :
829 Patients enrolled
Trial Details
Trial ID
NCT00151892
Start Date
April 8 2005
End Date
September 7 2009
Last Update
June 14 2021
Active Locations (142)
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1
Birmingham Gastroenterology Associates
Birmingham, Alabama, United States, 35209
2
Connecticut Gastroenterology Institute
Bristol, Connecticut, United States, 06010
3
Washington Gastroenterology
Washington D.C., District of Columbia, United States, 20010
4
Southern Clinical Research Consultants
Hollywood, Florida, United States, 33021