A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis
Phase 4
- Conditions
- ulcerative colitis
- Registration Number
- JPRN-UMIN000003952
- Lead Sponsor
- Department of lower gastroenterology, Hyogo College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients with severely active disease (2) Patients have undergone a colectomy (3) Patient having pregnancy or having the possibility of pregnancy (4) Patient giving the breast to a baby (5) Patient with severe renal dysfunction (6) Patient with severe liver dysfunction (7) Patient with severe infection (8) Patients with malignant disease, history of malignancy (9) Patients with past episode of severe drug allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical response (Mayo score) at 2, 12 weeks after treatment.
- Secondary Outcome Measures
Name Time Method (1) Mean maximum tacrolimus blood concentration (Cmax), mean time of Cmax (tmax), mean area under the blood concentration-time curve (AUC), trough level at day1. (2) Percentage of patients achieved trough tacrolimus whole blood levels between 10 and 15ng/ml within 2 weeks. (3) Dose of tacrolimus at 2weeks. (4) Safety