臨床研究等提出・公開システム

Date of registration	Aug. 05, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220797

Scientific Title	A randomized, double-blind, placebo-controlled, multi-center phase II study for the evaluation of efficacy and safety of CS-8958 in patients with influenza virus infection
Public Title	CS-8958 Taiwan Phase 2 study

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 COMPANY, LIMITED
	Address	http://www.daiichisankyo.co.jp/contact/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		180
Study Type		Interventional
Study Design	Study Design	Randomized double-blind, placebo controlled, parallel group, multi-center study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	-Clinical diagnosis of influenza -Ear temperature of > or = to 37.8 degrees C
	Exclusion Criteria	-Infection by bacteria species and/or virus other than influenza virus -Chronic respiratory disease, cardiovascular disease, renal dysfunction, metabolic disorder, immunologic disease and/or other severe complications
	Minimum Age	18age old over
	Maximum Age	64age old under
	Gender	Both
Health Condition or Problem Studied		influenza virus A or B infection
Intervention(s)		investigational material(s) Generic name etc : CS-8958 INN of investigational material : laninamivir Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material : CS-8958 powder to be inhaled one time control material(s) Generic name etc : CS-8958 placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : placebo powder to be inhaled one time
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Time to resolution of fever
Secondary Outcome		-The safety of CS-8958 in patients with influenza virus infection -The dose response of CS-8958 based on the efficacy

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-090826
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Sept. 08, 2011	Detail	Changes
7	Sept. 08, 2011	Detail	Changes
6	Sept. 02, 2011	Detail	Changes
5	Jan. 27, 2011	Detail	Changes
4	Nov. 30, 2010	Detail	Changes
3	Nov. 30, 2010	Detail	Changes
2	Aug. 05, 2009	Detail	Changes
1	Aug. 05, 2009	Detail

List of change history