Status:
COMPLETED
Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan
Lead Sponsor:
AstraZeneca
Conditions:
Crohn's Disease
Eligibility:
All Genders
15-130 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's disease affectin...
Detailed Description
A multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn's Disease (CD) in Japan
Eligibility Criteria
Inclusion
- 15 years of age or older
- Main active disease of the ileal, ileocecal region, and/or ascending colon - - If treated with partial nutrition treatment (≤1200 kcal/day) or if treated with azathioprine (≤2.0 mg/kg/day) or 6-mercaptopurine (≤1.2 mg/kg/day), 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01514240
Start Date
February 1 2012
End Date
September 1 2014
Last Update
October 31 2016
Active Locations (25)
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1
Research Site
Chikushino-shi, Japan
2
Research Site
Fukuoka, Japan
3
Research Site
Fukuyama-shi, Japan
4
Research Site
Hirosaki-shi, Japan