Efficacy and safety of extended administration by max dose mesalamine on induction therapy for mild to moderate ulcerative colitis
- Conditions
- ulcerative colitis
- Registration Number
- JPRN-UMIN000032961
- Lead Sponsor
- Department of Inflammatory Bowel Disease, Division of Internal Medicine Hyogo College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Not provided
1. Patients who had been treated with topical therapy (enema, suppository) within one month at the study inclusion. 2. Patients who have been treating by oral steroid, immunomodulator,Immunosuppresser (Tacrolimus), Cytapheresis, Biologics in their clinical relapse phase within one month at the study inclusion. 3. Patients with Crohn's disease. 4. Patients with gastric ulcer. 5. Patients with history of intestinal surgery. 6. Patients with pathogenic bacterium in stool examined by stool culture inspection. 7. Patients with allergy to Mesalazine. 8. Patients with allergy to Salicylic acid. 9. Patients with severe renal failure: eGFR<30 mL/min/1.73 m*2. 10. Patients with severe liver failure: AST or ALT>3 times of the upper limit of normal. 11. Patients who have been included other clinical trial. 12. Patients who is determined inappropriate to include to this study by the investigator. *Clinically relapse is defined as the phase in SCCAI score increased from<=2 to 3>=.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in remission rate in study population with time. Clinical remission was defined as the status in SCCAI score<=2.
- Secondary Outcome Measures
Name Time Method 1.Change in response rate in study population with time.Clinical response was defined as the status in decrease in SCCAI score by>=2 points in comparison to initial SCCAI. 2.Change in SCCAI score in study population with time. 3.Adverse effect