Phase III Study Comparing Association of Anti-inflammatory and Anti-rheumatic
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 375
- 主要终点
- Efficacy measured by decrease in score algofunctional Lequesne index after 12 weeks from the start of treatment
研究概览
简要总结
Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis.
详细描述
Evaluation after 12 weeks of treatment, in 3 arms, the efficacy and safety of the association.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signs the Informed Consent Form
- •Age between 40 and 85 years
- •osteoarthritis of the knee according to clinical and radiological criteria of the American College of Rheumatology
排除标准
- •Cardiovascular disease
- •Serious chronic comorbidity
- •Hypersensitivity to any component of the study drugs
- •body mass index> 30 kg / m²
研究组 & 干预措施
Kit 1 ( ML + CG ) + P
One sachet meloxicam and glucosamine and 1 placebo tablet once a day for 12 weeks One sachet
干预措施: Meloxicam and Glucosamine (Drug)
Kit 2 ( ML + P)
One tablet of meloxicam and one sachet of placebo once per day for 12 weeks
干预措施: Meloxicam (Drug)
Kit 3 ( P+ GC)
One sachet of glucosamine and one tablet placebo once a day for 12 weeks
干预措施: Glucosamine (Drug)
结局指标
主要结局
Efficacy measured by decrease in score algofunctional Lequesne index after 12 weeks from the start of treatment
时间窗: 12 weeks
Decrease in score of algofunctional Lequesne index after 12 weeks from the start of treatment
次要结局
- Safety measured by frequency of adverse event(12 weeks)