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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 23 April 2019
Main ID:  JPRN-JapicCTI-080566
Date of registration: 09/04/2008
Prospective Registration: Yes
Primary sponsor: AstraZeneca
Public title: A Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
Scientific title: A Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
Date of first enrolment:
Target sample size:
Recruitment status:
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-080566
Study type:  INTERVENTIONAL
Study design:  Randomized, Double-Blind, Placebo Control, Parallel Assignment Study  
Phase:  2
Countries of recruitment
Contacts
Name:    
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Affiliation: 
Name: AstraZeneca KK Clinical Trial Information   
Address:  RD-clinical-information-Japan@astrazeneca.com
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Key inclusion & exclusion criteria
Inclusion criteria: Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Inclusion Criteria:
- Female or male aged >=18 and =< 65 years
- Diagnosis of Crohn's Disease
Exclusion Criteria:
- Having ileostomy or pouch and/or colostomy
- Having previous gastric surgery
- Having a known or suspected systemic infection

Exclusion criteria:

Age minimum: 18
Age maximum: 65
Gender: BOTH
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Intervention name : Budesonide
Dosage And administration of the intervention : Oral
Primary Outcome(s)
Safety/Efficacy Primary Outcome Measures: -The primary outcome variable in this study is the remission after 8-week treatment defined by a CDAI score of =<150. Secondary Outcome Measures: -The secondary outcome variables are Remission after 2-week and 4-week treatment, Time to first remission, change in CDAI score, safety data.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Refer to the information of contact(s)
Secondary Sponsor(s)
Ethics review
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Results
Results available:
Date Posted:
Date Completed:
URL:
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