Examination on mucosal healing in mild to moderate active ulcerative colitis with mesalazine: a multicentre prospective open study
Not Applicable
- Conditions
- lcerative colitis
- Registration Number
- JPRN-UMIN000010668
- Lead Sponsor
- Dokkyo Medical University
- 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.Moderate, severe or fulminating active ulcerative colitis. 2.Use of oral 5-ASAs more than 4g/day within 2 weeks prior to study entry. 3.Introduce or increase the dosage of Steroids (intravenous infusion, oral), biologics or CAP within the last 90 days. 4.Increase the dosage of immunomodulators within the last 90 days. 5.Introduce or increase the treatment in the observation period. 6.Possible or documented pregnancy. 7.Experience of hypersensitivity to mesalazine. 8.Malignant disease or its history. 9.Patients who are considered inappropriate by investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mucosal healing rate at 12 weeks
- Secondary Outcome Measures
Name Time Method Maintainance of remission with once-daily oral mesalazine in patients achieved mucosal healing. Effect of long-term administration of oral mesalazine in patients with persistent endoscopically active UC.