Clinical trial
A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.
NCT00151944 is registered in ClinicalTrials.gov with Shire as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.
- Lead sponsor
- Shire
- Phase
- Phase 3
- Overall status
- Completed
- Start date
- November 26, 2003
- Completion date
- March 13, 2006
- Enrollment
- 400
- Sites
- Not reported
Conditions
As the registry lists them; a condition with its own page is linked.