drugset / Trial / NCT00862121
A Study With Pentasa in Patients With Active Crohn's Disease
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose and a 4 g evening dose is efficacious in active mild to moderate CD.
Timeline
- Start
- 2009-04
- Primary completion
- 2010-10
- Completion
- 2010-10
Outcome
Missed primary endpoint
Stopped (Enrollment): “Terminated due to poor recruitment”
registry Mesalazine vs Placebo; p = 0.231; Odds Ratio (OR) 0.212 (95% CI 0.017 to 2.683); Regression, Logistic NCT00862121 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mesalamine | Small molecule | 6 g | Oral |