臨床研究等提出・公開システム

Date of registration	July. 29, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220783

Scientific Title	A Phase II/III Study of CS-8958 in Pediatric Patients -A randomized double-blind controlled study of CS-8958 comparing with oseltamivir phosphate in patients with influenza virus infection aged 9 years or younger -
Public Title	A Phase II/III Study of CS-8958 in Pediatric Patients aged 9 years or younger

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/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		180
Study Type		Interventional
Study Design	Study Design	Multicenter, Randomized, 3-parallel-group, Double-blind, Active-controlled study
Study Design	Objective
Phase		2-3
Key inclusion & exclusion criteria	Inclusion Criteria	Patients judged as positive for influenza virus infection using an influenza rapid diagnostic kit. Patients who have an axillary temperature >=38.0°C when giving informed consent to the study. Patients judged to be capable to inhale the study drug using specific inhaler.
	Exclusion Criteria	Patients suspected of having infection by bacteria species and/or virus other than influenza virus occurring within 1 week before giving informed consent. Patients who have occurrence of any influenza-like symptom within 1 week before giving informed consent. Patients with any chronic respiratory disease, cardiovascular disease, nervous system disorder, renal dysfunction, metabolic disorder, immunologic disease, and/or other severe complications.
	Minimum Age	No limit
	Maximum Age	9age old under
	Gender	Both
Health Condition or Problem Studied		Type A or type B influenza virus 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 to be inhaled once control material(s) Generic name etc : Oseltamivir phosphate INN of investigational material : oseltamivir Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material : Oseltamivir phosphate to be administered orally
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Time to alleviation of influenza illness -
Secondary Outcome		Time to alleviation of cough and nasal symptom Time for body temperature returned -

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-090812
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
8	Dec. 17, 2018	(this page)	Changes
7	Sept. 08, 2011	Detail	Changes
6	Sept. 08, 2011	Detail	Changes
5	Jan. 27, 2011	Detail	Changes
4	Nov. 30, 2010	Detail	Changes
3	Nov. 30, 2010	Detail	Changes
2	Aug. 18, 2009	Detail	Changes
1	July. 29, 2009	Detail

List of change history