A Phase III Study of SI-613 in Patients with Knee Osteoarthritis (confirmatory study)

SEIKAGAKU CORPORATIO0 个研究点目标入组 440 人开始时间: 2017年3月14日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Diagnosis of osteoarthritis of the knee according to American College of Rheumatology criteria at the time of screening.
•Kellgren-Lawrence score grade 2 or 3 in an Antero-posterior weight-bearing x-ray of the target knee joint in the standing position taken at the time of screening.
•Subjects who are willing to discontinue pain medication except as permitted per protocol from the start date of screening to the end of Week 24 after the first injection (using acetaminophen as a rescue medication is permitted for breakthrough pain control).

•Secondary OA resulting from trauma or the other diseases in the target knee
•Subjects who have pain in lower extremity other than knee OA if it would interfere with the evaluation of the target knee or have OA of the hip or ankle at screening and Week 0 before injection.

发起方

SEIKAGAKU CORPORATIO