臨床研究等提出・公開システム

Date of registration	Aug. 01, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221872

Scientific Title	A Phase 2/3 Study of S-524101 in the Patients with Perennial Allergic Rhinitis
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	Shionogi & Co., Ltd.
	Address	http://www.shionogi.co.jp/information/inquiry_entrance.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Multicenter, double-blind, parallel-group comparative study
Study Design	Objective
Phase		2-3
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who have a history of symptomatic allergic rhinitis for two or more years. Patients who are positive for allergy tests for house dust mite.
	Exclusion Criteria	Patients with allergic rhinitis, conjunctivitis or asthma due to other antigens which could confound accurate symptom assessment during study.
	Minimum Age	12age old over
	Maximum Age	64age old under
	Gender	Both
Health Condition or Problem Studied		Allergic rhinitis
Intervention(s)		investigational material(s) Generic name etc : S-524101 INN of investigational material : Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational material : Sublingual
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy
Secondary Outcome

Primary Sponsor	SHIONOGI & 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-121917
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
8	Dec. 17, 2018	(this page)	Changes
7	Dec. 28, 2015	Detail	Changes
6	May. 09, 2014	Detail	Changes
5	May. 09, 2014	Detail	Changes
4	Mar. 15, 2013	Detail	Changes
3	Mar. 15, 2013	Detail	Changes
2	Aug. 01, 2012	Detail	Changes
1	Aug. 01, 2012	Detail

List of change history