Efficacy and safety of extended administration by max dose mesalamine on induction therapy for mild to moderate ulcerative colitis - CATHEDRAL study

Department of Inflammatory Bowel Disease, Division of Internal Medicine Hyogo College of Medicine0 个研究点目标入组 150 人开始时间: 2018年6月12日最近更新: 2023年10月17日

适应症

试验速览

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•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>=.

发起方

Department of Inflammatory Bowel Disease, Division of Internal Medicine Hyogo College of Medicine