NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-121765

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedCrohn's Disease
Date of first enrollment
Target sample size
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : D9421-C Dosage And administration of the intervention : 9mg, Oral once daily Control intervention name : Mesalazine Dosage And administration of the control intervention : 1g, Oral three times a day

Outcome(s)

Primary OutcomeClinical efficacy change defined by a score of 180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after 8-week treatment the remission after 8-week treatment defined by a CDAI score of 150 or less
Secondary OutcomeRemission after 2-week and 4-week treatment CDAI score of 150 or less Change in CDAI score Time to the first remission Clinical improvement a remission (ie, CDAI score of 150 or less) or a decrease in CDAI score of at least 100 from baseline after 2-week, 4-week, and 8-week treatments Clinical improvement a remission (ie, CDAI score of 150 or less) or a decrease in CDAI score of at least 70 from baseline after 2-week, 4-week, and 8-week treatments To evaluate the change in disease specific health-related quality of life (HRQL) a score of 180-400 on the CDAI by assessment of the Inflammatory Bowel Disease Questionnaire (IBDQ) total score and all sub scores

Key inclusion & exclusion criteria

Age minimum15
Age maximum
GenderBOTH
Include criteria- 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
Exclude criteria- 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

Related Information

Contact

public contact
Name AstraZeneca KK Clinical Trial Information
Address RD-clinical-information-Japan@astrazeneca.com
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scientific contact
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