EUCTR2017-004581-10-PL进行中（未招募）1 期
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. ROCCELLA Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 852
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male patients or female patients of non-childbearing potential
- •Age between 40 to 75 years (both inclusive) for male patients and female surgically sterile patients, and 50 to 75 years (both inclusive) for postmenopausal female patients
- •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
排除标准
- •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) other than intervention for hallux valgus with full clinical recovery after surgery
- •Any surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study
- •Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study
- •Other current or medical history pathologies affecting the target 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, or the presence of pacemaker or any other implanted electronic devices
研究者
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