The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study II
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 650
- 主要终点
- Change from baseline in the WOMAC Composite Pain Score
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of TDS-943 (topical diclofenac spray) compared to oral celecoxib and placebo in subjects with osteoarthritis of the knee. The main hypotheses are that TDS-943 will be better than placebo and no worse than celecoxib.
详细描述
This is a multicenter, outpatient, multiple-dose, placebo- and active controlled, double-blind, double-dummy parallel group, randomized (stratified by unilateral vs. bilateral knee OA) trial. The trial will enroll subjects who have been diagnosed with OA of the knee (confirmed by weight-bearing x-ray) and whose condition is in flare at baseline. Subjects who qualify to enter the study will be randomized to topical TDS-943 40 mg bid, oral celecoxib 200 mg qd, or placebo in a 3:2:2 ratio.
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
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females in generally good health at least 40 years of age
- •Osteoarthritis (OA) of at least one knee, verified by a weight-bearing radiograph
- •Subject has taken an oral NSAID or analgesic at least 3 days during the past 30 days to treat knee OA pain
排除标准
- •Females who are pregnant or lactating or who may become pregnant
- •Hypersensitivity (exacerbations of asthma, rhinitis, or urticaria) to sulfonamides, acetaminophen, diclofenac, celecoxib, aspirin, or any other NSAID
- •History of myocardial infarction, congestive heart failure, stroke, coronary-artery bypass graft surgery, or any other significant cardiovascular disease, or is on any form of anticoagulation therapy other than low-dose aspirin (no more than 325 mg/day)
研究组 & 干预措施
1
placebo
干预措施: placebo (Other)
2
celecoxib 200 mg qd p.o.
干预措施: celecoxib (Drug)
3
TDS-943 40 mg bid topically
干预措施: TDS-943 (topical diclofenac sodium 4% spray) (Drug)
结局指标
主要结局
Change from baseline in the WOMAC Composite Pain Score
时间窗: 30 days
次要结局
- Change from baseline in the WOMAC Composite Stiffness and Composite Function Scores, Change from Baseline in the Subject's Global Assessment of Arthritic Condition, Change from baseline in the Subject's Assessment of OA Pain, %OMERACT-OARSI responders(30 days)