drugset / Trial / NCT00577473
Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet
Timeline
- Start
- 2001-02
- Primary completion
- 2003-02
- Completion
- 2003-02
Outcome
Missed primary endpoint
registry p = 0.4411; Risk Difference (RD) 0.0455 (95% CI -7.01 to 16.11) NCT00577473 ↗
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 |