NCT01967550已完成3 期
A 4-week, Randomized, Double-blind, Multi-center, Vehicle-controlled, Parallel Group Study to Assess the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel for the Relief of Signs and Symptoms in Patients With Knee Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 304
- 主要终点
- Measure: Pain On Movement (POM)
研究概览
简要总结
This study will evaluate the efficacy and safety of diclofenac DDEA 2.32 % in patient suffering from knee osteoarthritis (OA).
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 (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 50 years old;
- •Symptomatic OA of one or both knees, according to ACR criteria, diagnosed at least 6 months previously;
- •Pain in either knee originates in the knee (not referred pain from other sites, such as hip or back) and no other cause of pain than knee OA;
- •Have used oral NSAIDs or COXIBs for the knee OA pain (including aspirin if ≥ 500 mg and used in this indication), at least one dose per day, for not less than 10 days out of the 14 days preceding the screening visit and also within the 24 hours preceding the screening visit;
- •Be able to tolerate rescue medication with only 500 mg paracetamol (APAP) taken in doses of 1-2 tablets up to a maximum of 6 tablets (3 grams) per day for the duration of the study
排除标准
- •Partial or total replacement of either knee joint, past or planned/expected during study duration.
- •OA of the knee due to other underlying conditions, such as gout, chondrocalcinosis, hemochromatosis, joint infections, neuropathia, or severe traumatic joint damage (however, common risk factors, such as obesity and past meniscectomy or ligament rupture and repair, are allowed);
- •History of systemic inflammatory (autoimmune) disease (rheumatoid arthritis, systemic psoriasis, systemic lupus erythematosus, systemic sclerosis, etc.) or laboratory values indicative of such disease with subsequent diagnosis by a physician;
- •Fibromyalgia within the previous year;
- •Allergy or asthma to diclofenac, APAP, aspirin, other NSAIDs or any of the ingredients in the gel (i.e. isopropyl alcohol, propylene glycol, or butylhydroxytoluene), or any other contraindication for the study drug or the rescue medication
研究组 & 干预措施
diclofenac diethylamine, DDEA 2.32% gel
Experimental
diclofenac diethylamine, DDEA 2.32% gel
干预措施: diclofenac diethylamine, DDEA 2.32% gel (Drug)
Placebo
Placebo Comparator
Vehicle control
干预措施: Placebo (Drug)
结局指标
主要结局
Measure: Pain On Movement (POM)
时间窗: 2 weeks
POM will be assessed by subject on a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with higher score indicating higher levels of pain.
次要结局
未报告次要终点
研究者
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