Crohn's Disease
Conditions
Interventions
investigational material(s)
Generic name etc : D9421-C
INN of investigational material :
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administration for Investig
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical 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
| Measure | Time frame |
|---|---|
| Remission 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 | — |
Outcome results
None listed