A repeated oral dose study in healthy Japanese male subjects and a multi-center, placebo-controlled, randomized, double-blinded, parallel-group comparative study in Japanese osteoarthritis patients

ONO PHARMACEUTICAL CO.,LTD.0 个研究点目标入组 124 人开始时间: 2018年2月26日最近更新: 2023年10月17日

适应症

试验速览

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•1. Healthy Japanese adult male subject
•2. BMI (at the time of screening): 18.5 kg/m2 or more, less than 25.0 kg/m2
•Age : 20 to 45 years
•1. Japanese osteoarthritis (OA) patients
•2. BMI (at the time of screening): 18.5 kg/m2 or more, less than 39.0 kg/m2
•3. Patients with knee symptoms in >=6 months prior to the start of screening period and were diagnosed with OA already at the time of >=6 months prior to the start of screening period
•4. Patients with knee pain caused by OA for >=4 days a week in >=3 months prior to the start of screening period
•5. Patients who meet the criteria of OA (Clinical) defined in the American College of Rheumatology Criteria (ACR) at the time of screening.
•6. Patients with Kellgren-Lawrence (KL) Grade 2 to 4 according to a knee finding of X-ray photograph at the time of screening
•7. Patients with insufficient analgesic effects of same NSAIDs which are continuously used with consistent dose and administration in >=14days prior to the start of screening period.
•Age : 40 to 75 years
•Sex : male and female

•1. Subjects who have been on a treatment for diseases such as respiratory, cardiovascular, central nerve system, digestive system, hepatic, renal, hematopoietic or endocrine function diseases, or subjects with a history of these diseases
•2. Subjects with a history of serious allergy to drugs or food
•3. Subjects with a history of drug dependence or alcohol dependence
•1. Patients with secondary osteoarthritis
•2. Patients who have received an artificial joint replacement or are planned to receive an artificial joint replacement during the study period on the diseased knee part of assessment leg
•3. Patients with a past history or concurrent diseases of articular diseases accompanied with other pain than osteoarthritis
•4. Patients with a past history or concurrent diseases of clinically significant nervous diseases
•5. Patients with a past history or concurrent diseases of psychiatric diseases

发起方

ONO PHARMACEUTICAL CO.,LTD.