SSJG-009 Phase II study

未提供0 个研究点目标入组 40 人开始时间: 待定

适应症

试验速览

暂无简介。

•The study will include patients who meet all of the following criterias:
•Japanese aged 20 years or older at the time of obtaining informed consent.
•At screening, patients who have pain due to physical stimulation by the denture, and inflammation is observed at the site of the pain.
•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.

•Patients who meet any of the following conditions will be excluded from the study:
•Patients who have pain unrelated to dentures at screening and are judged that may affect the evaluation of this study.
•Patients who have used medications, which are considered to affect evaluation of the investigational product, from the day before administration of the study drug.
•Patients who require treatment with prohibited concomitant medications or prohibited concomitant therapies specified in the study protocol.
•Patients with severe diseases of the cardiac, vascular, renal, hepatic, gastrointestinal, endocrine, neurological, dermatological, metabolic, or immune systems.
•Patients who have aspirin-induced asthma or a history of aspirin-induced asthma.
•Patients with a history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis.
•Patients with a history of hypersensitivity to the investigational product or to drugs with a similar chemical structure.
•Patients who are otherwise judged by the investigator or subinvestigator to be unsuitable for participation in this study.

发起方

未提供