Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
This study has been completed.
Information provided by:
First received: September 7, 2005
Last updated: June 26, 2009
Last verified: December 2008
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Shire:
Primary Outcome Measures:
- Treatment emergent adverse events over 12 months.
Secondary Outcome Measures:
- Time to relapse
- Subject compliance
- Number of subjects in remission after 12 months
- UC-DAI score
- Patient questionnaire
|Study Start Date:||November 2003|
|Study Completion Date:||October 2006|
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