臨床研究等提出・公開システム

Date of registration	May. 29, 2024
Last modified on	Sept. 11, 2024
Trial ID	jRCT2031240126

Scientific Title	TK-042 Phase III Clinical Study Long-term administration study in children with perennial allergic rhinitis
Public Title	TK-042 Phase III Clinical Study Long-term administration study in children with perennial allergic rhinitis

Contact for Scientific Queries	Name	Nishiyama Kenichi
	Affiliation	Teikoku Seiyaku Co., Ltd.
	Address	6-6, Nihonbashi Kobunacho, Chuo-ku, Tokyo
	Telephone	+81-3-6264-9123
	E-mail	clinical_trial@teiyaku.co.jp
Contact for Public Queries	Name	Clinical Development Department
	Affiliation	Teikoku Seiyaku Co., Ltd.
	Address	6-6, Nihonbashi Kobunacho, Chuo-ku, Tokyo
	Telephone	+81-3-6264-9123
	E-mail	clinical_trial@teiyaku.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		July. 01, 2024
Actual date of first enrollment		July. 13, 2024
Target sample size		60
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- >= 7 to < 12 years of age. - Have positive (class >= 2) specific IgE antibodies test (e.g., CAP-RAST, AlaSTAT 3g, etc.) for antigens of perennial allergic rhinitis.
	Exclusion Criteria	- Have concomitant nasal disorders (e.g., nasal polyps, nasal septum deviation, hypertrophic rhinitis, etc.) or infectious diseases (e.g., upper respiratory tract inflammation, sinusitis, infectious rhinitis, eye infections, etc.) to a degree that would interfere with the efficacy evaluation. - Have non-allergic rhinitis (e.g., vasomotor, infectious, drug-induced, etc.) or history of non-allergic rhinitis. - Have undergone coagulation (e.g., laser) or ablative surgery for the treatment of nasal symptoms within 1 year prior to obtaining consent. - Have uncontrolled mild and moderate bronchial asthma (patients with conditions that require the use of injectable, oral, or inhaled steroid preparations), or severe bronchial asthma. - Have a history of hypersensitivity to antihistamines, including this drug, or any ingredient of investigational drugs. - Have severe hepatobiliary disorders. - Have severe renal or urinary disorders.
	Age Minimum	7age old over
	Age Maximum	12age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		perennial allergic rhinitis
Intervention(s)		Placebo administered orally as 1 tablet once daily for 1 week, TK-042 administered orally as 1 tablet once daily for 12 weeks.
Primary Outcome(s)		Safety endpoints (laboratory tests, vital signs, adverse events)

Primary Sponsor	Teikoku Seiyaku Co., Ltd.

Name of Certified Review Board	Medical Corporation Shinanokai Shinanozaka Clinic Institutional Review Board
Address	Yotsuya Medical Bldg. 3F, 20, Samon-cho, Shinjuku-ku, Tokyo, Tokyo
Telephone	+81-3-5366-3006
E-Mail	scl-irb@shinanokai.com
Approval Status	Approval
Date of approval	June. 25, 2024

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka, Tokyo
Telephone	+81-6-6395-9000
E-Mail	ophach_irb@heishinkai.com
Approval Status	Approval
Date of approval	June. 25, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Sept. 11, 2024	(this page)	Changes
3	July. 30, 2024	Detail	Changes
2	July. 16, 2024	Detail	Changes
1	May. 29, 2024	Detail

List of change history