NCT00722852已完成3 期
Multicentre, Randomized, Double-blind, Placebo-controlled Study of Safety and Efficacy of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee
IDEA AG37 个研究点 分布在 1 个国家目标入组 555 人开始时间: 2008年6月最近更新:
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
- 入组人数
- 555
- 试验地点
- 37
- 主要终点
- pain subscale of the WOMAC
研究概览
简要总结
The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in Diractin®.
详细描述
The study will investigate safety and efficacy of Diractin® at relieving signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 46 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed and dated
- •Age > 45 years
- •Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee
排除标准
- •Skin lesions or dermatological diseases in the treatment area
- •Directly or indirectly involved in the conduct and administration of this study
- •Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin®
- •Pregnancy or lactation
- •Residents of psychiatric wards, prisons or other state institutions
- •Malignancy within the past 2 years
- •Depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study
- •Schizophrenia
- •Neuropathic pain and any other pain condition requiring chronic use of pain medication
- •Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen and to ingredients of the IMP
- •Preexisting asthma or bronchospasm after taking aspirin or other NSAIDs
- •Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study
研究组 & 干预措施
1
Experimental
干预措施: ketoprofen in Diractin® (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
pain subscale of the WOMAC
时间窗: week 12
次要结局
- Patient global assessment of response to therapy(week 12)
- function subscale of the WOMAC(week 12)
研究者
研究点 (37)
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