drugset / Trial / NCT00073021
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.
Timeline
- Start
- 2000-09
- Primary completion
- 2003-09
- Completion
- 2003-09
Outcome
Met primary endpoint
registry NUMBER Asacol 2.4 g/Day: 59.2 Percentage of Participants NUMBER Asacol 4.8 g/Day: 71.8 Percentage of Participants NCT00073021 ↗
registry Asacol 2.4 g/Day vs Asacol 4.8 g/Day; p = 0.0357; Difference in Success Rates 12.543 (95% CI 0.96 to 24.12) NCT00073021 ↗
Publications
- Orchard TR, van der Geest SA, Travis SP. Randomised clinical trial: early assessment after 2 weeks of high-dose mesalazine for moderately active ulcerative colitis - new light on a familiar question. Aliment Pharmacol Ther. 2011 May;33(9):1028-35. doi: 10.1111/j.1365-2036.2011.04620.x. Epub 2011 Mar 8.
- Lichtenstein GR, Ramsey D, Rubin DT. Randomised clinical trial: delayed-release oral mesalazine 4.8 g/day vs. 2.4 g/day in endoscopic mucosal healing--ASCEND I and II combined analysis. Aliment Pharmacol Ther. 2011 Mar;33(6):672-8. doi: 10.1111/j.1365-2036.2010.04575.x. Epub 2011 Jan 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mesalamine | Small molecule | 2.4 g | Oral |
| Subject | Mesalamine | Small molecule | 4.8 g | Oral |