NCT00643071

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

Tacrolimus (FK506) P-III, Open-label Study in Severe Refractory Ulcerative Colitis Patients or Patients Who Attended and Received Placebo in F506-CL-1107 Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 16 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 study can participate in this study. Patients will receive tacrolimus for a maximum of 12 weeks in an open-label study manner. Improvement of Disease Activity Index (DAI) score and other efficacy scores will be evaluated during the drug administration period.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Tacrolimus	Oral

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-03-26
• Last updated: 2014-08-26

Locations

6 sites across 1 country: Japan