Segmental Endoscopic Evaluation of Combined Oral and Topical Mesalazine (Pentasa®) in patients with mild-to-moderate Ulcerative Colitis (UC)
- Conditions
- ulcerative colitis
- Registration Number
- JPRN-UMIN000010168
- Lead Sponsor
- Toho University Sakura Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 60
Not provided
1)Patients receiving topical mesalazine, topical sulfasalazine within 14 days prior to study entry 2)Patients receiving any steroid within 14 days prior to study entry 3)Patients treated with immunosuppressive agents or anti TNF-a antibody during 90 days prior to study enrolment 4)Patients receiving cytapheresis within 14 days prior to study entry 5)Patients who have allergy to salicylates 6)Patients who have experienced serious adverse effect elicited by mesalazine 7)Patients who have complicated malignant disease 8)Patients who are pregnant or possibly pregnant 9)Patients suspected to remain the effect of intervention in other clinical researches 10)Patients who have any condition that might interfere with study assessments, judged by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mucosal healing defined as Mayo endoscopic score = 0, 1
- Secondary Outcome Measures
Name Time Method Endoscopic improvement by segmental endoscopic evaluation Improvement of disease activity in UCDAI score and/or UCDAI sub-scores