Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
This study has been completed.
First Posted: September 9, 2005
Last Update Posted: June 9, 2014
Information provided by:
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
Intervention Model: Parallel Assignment
Masking: None (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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