臨床研究等提出・公開システム

Date of registration	April. 09, 2008
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220544

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
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	AstraZeneca KK
	Address	RD-clinical-information-Japan@astrazeneca.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Randomized, Double-Blind, Placebo Control, Parallel Assignment Study
Study Design	Objective
Phase		2
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
	Minimum Age	18age old over
	Maximum Age	65age old under
	Gender	Both
Health Condition or Problem Studied		Crohn's Disease
Intervention(s)		investigational material(s) Generic name etc : Budesonide INN of investigational material : Therapeutic category code : 245 Adrenal hormone preparations Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		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

Primary Sponsor	AstraZeneca
Secondary Sponsor

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Name of Research Funding

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Address of IRB
Phone Number of IRB
E-mail Address of IRB
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Date of Approval by IRB

Secondary ID No.	JapicCTI-080566
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Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Dec. 16, 2016	Detail	Changes
5	Dec. 16, 2016	Detail	Changes
4	July. 12, 2010	Detail	Changes
3	July. 12, 2010	Detail	Changes
2	April. 09, 2008	Detail	Changes
1	April. 09, 2008	Detail

List of change history