Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis
Not Applicable
Recruiting
- Conditions
- ulcerative colitis
- Registration Number
- JPRN-UMIN000005824
- Lead Sponsor
- Juntendo University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1. A patient who has had hypersensitivity to tacrolimus or ingredients of tacrolimus formulation. 2. A patient who is in treatment of cyclosporine or bozentan. 3. A patient who is in treatment of potassium sparing diuretics. 4. A patient who is pregnant, may be pregnant, breast-feeds or hopes to be pregnant in the study period. 5. A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical and endoscopic remission rate at 12 weeks after the start of protocol treatment
- Secondary Outcome Measures
Name Time Method Achievement rate of the target trough levels (7 to 12 ng/mL) of the blood trough concentrations of tacrolimus at 1 and 2 weeks after start of protocol treatment Correlation between the blood trough concentrations of tacrolimus and efficacy at 1 and 2 weeks after start of protocol treatment