Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy.
Phase 3
- Conditions
- lcerative colitis
- Registration Number
- JPRN-UMIN000003785
- Lead Sponsor
- Department of Internal medicine, Division 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
- 80
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
- Secondary Outcome Measures
Name Time Method