Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients

Astellas

Status and phase

Completed

Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: Placebo

Drug: tacrolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00347048

F506-CL-1107

Details and patient eligibility

About

This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in responders.

Enrollment

62 patients

Sex

All

Ages

16 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Moderate to severe refractory UC patients
Disease activity: more than 4 times of stool a day, bloody stool, moderate to severe endoscopic finding
Steroid resistance or dependence to meet at least one of the following condition:no efficacy with more than 40mg/day or 1mg/kg/day of steroid over at least 1 week, no efficacy with 30-40mg/day of steroid over at least 2 weeks,exacerbation along with steroid reduction

Exclusion criteria

Mild or fulminant type
Renal failure patients, hepatic failure patients
Patients taking 6-mercaptopurine, cyclosporin or other immunosuppressants within 12 weeks prior to entry
Patients who received LCAP or GCAP within 2 weeks prior to entry
Patients who changed the dose of steroid or started steroid within 2 weeks prior to entry.
Patients who changed the dose of steroid or started steroid within 1 week prior to entry in case they received more than 40 mg/ day or 1mg/kg/day of steroid just before the study.