A Multicentre, Double-blind, Randomised, Parallel-group, Phase3 Study to Assess Efficacy and Safety of D9421-C 9mg Versus Mesalazine 3g in Patients With Active Crohn's Disease (CD) in Japan

AstraZeneca0 个研究点开始时间: 2012年2月28日最近更新: 2023年10月17日

适应症

试验速览

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•Mein active disease of the ileal, ileocecal region, and/or ascending colon
•- If treated with partial nutrition treatment (1200kcal/day or less) or if treated with azathioprine (2.0mg/kg/day or less) or 6-mercaptopurine (1.2mg/kg/day or less), prior to randomisation until the study completion or discontinuation
•- Ability to read, write and to fill a diary card and HRQL questionnaire
•- Having mild to moderate active Crohn's disease, defined as CDAI score of 180-400 at baseline

•- Patient with CD lesion or status which may affect the evaluation of the efficacy (e.g. lesion only in the upper G-I, active anorectal lesion, abscess formation, stenosis, fistulae, ostomy, short bowel or other uncontrolled concomitant disease)
•- Patient who need any concomitant treatment for CD that may affect the assessment for efficacy of the study drug
•- Patient who need any medication which is prohibited due to suspected influence to metabolism of the study drug
•- Patient who is judged to be inadequate to participate in this study from the safety point of view Patient with well-founded doubt about protocol violation

发起方