Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
- Registration Number
- NCT00347048
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 tacrolimus - 2 Placebo -
- Primary Outcome Measures
Name Time Method Improvement of Disease activity index score (DAI score) 2 Weeks
- Secondary Outcome Measures
Name Time Method Changes of clinical severity and symptom 2 Weeks Endoscopic finding 2 Weeks Patients impression 2 Weeks Changes of DAI score ( Total & each item) 2 Weeks Amount of steroid 2 Weeks