Efficacy and safety of 3 doses of S201086/GLPG1972 administered orally once daily in patients with knee osteoarthritis. A 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled, dose-ranging study.

Institut de Recherches Internationales Servier0 个研究点目标入组 932 人开始时间: 2018年4月11日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•Male patients or female patients of non-childbearing potential
•Age between 40 to 75 years (both inclusive)
•Body weight > 40 kg, body mass index (BMI) < 40 kg/m2
•Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology
•History of knee pain for at least 6 months and on the majority of days (> 50%) during the preceding month
•Symptoms severity defined by a pain = 40 mm and = 90 mm on VAS (100 mm)
•Documented need for symptomatic as needed-treatment for OA in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 502
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 350

•Severe clinical knee malalignment according to the investigator
•Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral side)
•Knee prosthesis already foreseen within the study period (whichever side)
•Hip prosthesis recently implanted (< 1 year) or foreseen within the study period (whichever side)
•Previous osteotomy on the inferior limbs (whichever side)
•Surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study
•Arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study
•Other pathologies affecting the knee
•Any contraindication to MRI including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil

发起方