drugset / Trial / NCT00862121

A Study With Pentasa in Patients With Active Crohn's Disease

NCT00862121 ↗

Phase 3 Terminated 20 enrolled Ferring Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
Subject Mesalamine Small molecule 6 g Oral

Indications