Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis
Not Applicable
- Conditions
- lcerative colitis
- Registration Number
- JPRN-UMIN000026175
- Lead Sponsor
- Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) People with severe or fulminant ulcerative colitis. (Mayo score 2 or less, or less severe classification by Suzuki team of Ministry of Health, Labor and Welfare) 2) Patients undergoing total colon resection, subtotal puncture surgery etc. 3) Patients with liver dysfunction and renal dysfunction. 4) Patients undergoing antithrombotic therapy or anticoagulant therapy and patients with thrombocytopenia. 5) Pregnant women or patients who may be pregnant, breast-feeding patients. 6) Patients who are merging psychosis or psychiatric symptoms and are considered difficult to participate in the study. 7) Other patients who decided that the doctor in charge is inappropriate, such as a decline in compliance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the concentrations of 5-ASA and acetyl 5-ASA in rectal, cecal biopsy tissue, remission induction rate / maintenance rate (Mayo 1 or less)
- Secondary Outcome Measures
Name Time Method Drug efficacy rate (improvement of CAI by 30% or more), remission maintenance rate and duration, side effect occurrence rate, endoscopic findings, CRP, change amount of calprotectin in the stool