drugset / Trial / NCT00603733

Canadian Active & Maintenance Modified Pentasa Study

NCT00603733

Phase 3 Completed 288 enrolled Ferring Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative Colitis (UC) and also in maintenance of quiescent disease.

Timeline

Start
2007-10
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mesalamine Small molecule 2 g Oral
Comparator Mesalamine Small molecule 4 g Oral

Indications