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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.