臨床研究等提出・公開システム

Date of registration	July. 01, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222549

Scientific Title	A double-blind, placebo-control, randomized phase III study to evaluate the efficacy and safety of TAC-202 in patients with perennial allergic rhinitis
Public Title	A phase III study of TAC-202 in patients with perennial allergic rhinitis

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		750
Study Type		Interventional
Study Design	Study Design	Double-blind, randomized, placebo-controlled, parallel-group, multicenter
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects who have been diagnosed with perennial allergic rhinitis and who have had related symptoms for 2 years or longer. Subjects who showed positive in nasal provocation test with house dust disc.
	Exclusion Criteria	Subjects who previously developed anaphylaxis to antihistamine drugs, fexofenadine or ingredients of the investigational drug. Subjects with any of the following complications that may hinder efficacy evaluation - Vasomotor rhinitis, - Eosinophilic rhinitis, - Drug-induced rhinitis, - Viral conjunctivitis, - Otitis media, - Others (acute/chronic rhinitis, hypertrophic rhinitis, sinusitis, nasal polyps, repetitive nasal hemorrhage, treatment-requiring nasal septal deviation, etc.)
	Minimum Age	18age old over
	Maximum Age	74age old under
	Gender	Both
Health Condition or Problem Studied		Patients with perennial allergic rhinitis
Intervention(s)		investigational material(s) Generic name etc : TAC-202 INN of investigational material : Bilastine Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational material : TAC-202 20 mg tablet, once a day, oral administration control material(s) Generic name etc : Placebo tablet INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo tablet, once a day, oral administration Generic name etc : Fexofenadine INN of investigational material : Fexofenadine Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational material : Fexofenadine 60 mg tablet, twice a day, oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Mean change in total nasal symptom scores (TNSS; scores for rhinorrhea, sneezing, nasal congestion and nasal itching) To evaluete the symptoms score by subjects using the patient's diary card.
Secondary Outcome		QOL Japanese rhinoconjunctivitis quality of life questionnaire No 1 To evaluete the QOL score by patients using the QOL questionnaire Degree of satisfaction with treatment To evaluate the degree of patient's satisfaction with treatment Degree of improvement To evaluete the degree of improvement using the symptom score of the patient's diary card Incidences of adverse events and adverse drug reactions Systolic and diastolic pressure, Pulse, Temperature, Clinical lab, Physical examination, 12-lead ECG

Primary Sponsor	Taiho Pharmaceutical Co., Ltd.
Secondary Sponsor

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

Name of IRB	Osaka Pharmacology Clinical Research 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-142600
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Mar. 03, 2017	Detail	Changes
7	Mar. 03, 2017	Detail	Changes
6	June. 15, 2015	Detail	Changes
5	June. 15, 2015	Detail	Changes
4	July. 28, 2014	Detail	Changes
3	July. 28, 2014	Detail	Changes
2	July. 01, 2014	Detail	Changes
1	July. 01, 2014	Detail

List of change history