臨床研究等提出・公開システム

Date of registration	Feb. 02, 2026
Last modified on	Feb. 02, 2026
Trial ID	jRCT2031250699

Scientific Title	SSJG-009 Phase II study
Public Title	SSJG-009 Phase II study

Contact for Scientific Queries	Name	Fujisawa Kouichi
	Affiliation	Sunstar Inc.
	Address	Asia One Center 8F, 1-17 Koyochonaka, Kobe Higashinada-ku, Hyogo, Japan
	Telephone	+81-80-9937-4055
	E-mail	ssjg009@sunstar.com
Contact for Public Queries	Name	Fujisawa Kouichi
	Affiliation	Sunstar Inc.
	Address	Asia One Center 8F, 1-17 Koyochonaka, Kobe Higashinada-ku, Hyogo, Japan
	Telephone	+81-80-9937-4055
	E-mail	ssjg009@sunstar.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 10, 2026
Target sample size		40
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	The study will include patients who meet all of the following criterias: 1. Japanese aged 20 years or older at the time of obtaining informed consent. 2. At screening, patients who have pain due to physical stimulation by the denture, and inflammation is observed at the site of the pain. 3. Patients who have received sufficient explanation about the investigational product and the purpose and details of this study, have the ability to comply with study requirements, and have provided written informed consent to participate.
	Exclusion Criteria	Patients who meet any of the following conditions will be excluded from the study: 1. Patients who have pain unrelated to dentures at screening and are judged that may affect the evaluation of this study. 2. Patients who have used medications, which are considered to affect evaluation of the investigational product, from the day before administration of the study drug. 3. Patients who require treatment with prohibited concomitant medications or prohibited concomitant therapies specified in the study protocol. 4. Patients with severe diseases of the cardiac, vascular, renal, hepatic, gastrointestinal, endocrine, neurological, dermatological, metabolic, or immune systems. 5. Patients who have aspirin-induced asthma or a history of aspirin-induced asthma. 6. Patients with a history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis. 7. Patients with a history of hypersensitivity to the investigational product or to drugs with a similar chemical structure. 8. Patients who are otherwise judged by the investigator or subinvestigator to be unsuitable for participation in this study.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Mucosal inflammation caused by the physical stimulation of dentures
Intervention(s)		Before the efficacy assessment conducted in the clinic on Day 1, either SSJG-009 (0.2%), SSJG-009 (0.5%), or placebo (vehicle) will be administered. Thereafter, administration will be continued between before dinner on Day1 and before each meal (three times daily) through Day 2 to Day7.
Primary Outcome(s)		Change in NRS score compared to baseline
Secondary Outcome(s)		Patient impression score, overall clinical improvement rating, and oral mucosal findings.

Primary Sponsor	Sunstar Inc.

Name of Certified Review Board	Institute of Science Tokyo Hospital Institutional Review Board
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Tokyo
Telephone	+81-3-3813-6111
Approval Status	Approval
Date of approval	Jan. 27, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none