臨床研究等提出・公開システム

Date of registration	Jan. 18, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221355

Scientific Title	A phase IIa proof-of-concept study of TAC-201 in cedar pollinosis
Public Title	A POC Study of TAC-201

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	Taiho Pharmaceutical Co., Ltd.
	Address	toiawaseCD1@taiho.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Taiho Pharmaceutical Co., Ltd.
	Address	toiawase@taiho.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		96
Study Type		Interventional
Study Design	Study Design	Randomized, double-blind, placebo-controlled, parallel-group comparative study.
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Distinct symptoms of cedar pollinosis during the cedar pollen allergy season in 2010, with the severity of moderate or higher.
	Exclusion Criteria	Previous participation in the study of TAC-201.
	Minimum Age	20age old over
	Maximum Age	55age old under
	Gender	Both
Health Condition or Problem Studied		Cedar pollen allergy
Intervention(s)		investigational material(s) Generic name etc : TAC-201 INN of investigational material : Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational material : Multiple subcutaneous administration in a dose of 0.25 mg. control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Multiple subcutaneous administration of placebo.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy Proportion of symptom-free days(%) calculated by clinical symptom score.
Secondary Outcome		Safety Adverse events

Primary Sponsor	Taiho Pharmaceutical Co., Ltd.
Secondary Sponsor

Name of Funding Organization	Taiho Pharmaceutical Co., Ltd.
Name of Research Funding

Name of IRB	Medical Corporation Shinanokai, Shinanozaka Clinic IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Name of IRB	Life Extension Research Institute Foundation YANAGIBASHI Hospital 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-111392
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Nov. 01, 2012	Detail	Changes
5	Nov. 01, 2012	Detail	Changes
4	July. 20, 2011	Detail	Changes
3	July. 20, 2011	Detail	Changes
2	Jan. 27, 2011	Detail	Changes
1	Jan. 18, 2011	Detail

List of change history