Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients

Phase 3 Completed 32 enrolled Astellas Pharma Inc

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy will be evaluated.

Timeline

Start: 2006-09
Primary completion: 2008-05
Completion: 2008-05

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tacrolimus	Small molecule	—	Oral

Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients

Summary

Timeline

Drugs

Indications