Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial.
Phase 2
Recruiting
- Conditions
- s diseaseCrohn'
- Registration Number
- JPRN-UMIN000002796
- Lead Sponsor
- Department of Gastroenterology and Hepatology, Kyoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
(1)patients with severe active disease-massive bleeding case, perforating case(2)patients with severe cardiac disease, liver disease, respiratory disease (3)patients with renal disease and hyperkalemia (4)patients with malignant disease, history of malignancy (5)patients with severe infection (6)patient having pregnancy or having the possiblity of pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Crohn's disease activity index at 0.4.8 weeks after treatment
- Secondary Outcome Measures
Name Time Method (1)change of CRP (2)percentage of patients achieved remission after treatment (3)safty (4)percentage of pateints with decreasing more than 100 points of CDAI after treatment