臨床研究等提出・公開システム

Date of registration	Mar. 19, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220697

Scientific Title	Phase III study of SUN11031 for eating disorders
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	DAIICHI SANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/contact/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Diagnosis of anorexia nervosa (restricting type) or eating disorders not otherwise specified according to the DSM-IV diagnostic criteria.
	Exclusion Criteria
	Minimum Age	15age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Eating disorders (anorexia nervosa and eating disorders not otherwise specified)
Intervention(s)		investigational material(s) Generic name etc : SUN11031 INN of investigational material : Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : Subjects will receive 0 or 2.0 ug/kg of SUN11031 intravenously twice a day (before breakfast, before supper) for 20 days.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-090723
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	May. 15, 2012	Detail	Changes
7	May. 15, 2012	Detail	Changes
6	May. 11, 2011	Detail	Changes
5	May. 11, 2011	Detail	Changes
4	Jan. 27, 2011	Detail	Changes
3	April. 19, 2010	Detail	Changes
2	April. 13, 2010	Detail	Changes
1	Mar. 19, 2009	Detail

List of change history