Status:
COMPLETED
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
16-64 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00347048
Start Date
September 1 2006
End Date
April 1 2008
Last Update
August 26 2014
Active Locations (6)
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1
Chubu Region, Japan
2
Hokkaido Region, Japan
3
Kansai Region, Japan
4
Kanto Region, Japan