drugset / Trial / NCT00151944
Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.
Timeline
- Start
- 2003-11-26
- Primary completion
- 2006-03-13
- Completion
- 2006-03-13
Publications
- Results Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, Barrett K, Joseph R. Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. Gut. 2008 Jul;57(7):893-902. doi: 10.1136/gut.2007.138248. Epub 2008 Feb 13.
- Results Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, Barrett K, Joseph R. Effect of extended MMX mesalamine therapy for acute, mild-to-moderate ulcerative colitis. Inflamm Bowel Dis. 2009 Jan;15(1):1-8. doi: 10.1002/ibd.20580.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mesalamine | Small molecule | 1.2 g | — |
| Subject | Mesalamine | Small molecule | 2.4 g | — |