NCT01183624已完成4 期
A Multi-Center, Randomized, Double-Blind, Parallel, Placebo Control Study of a Traditional Chinese Medicine Topical Analgesic Patch in the Treatment of Osteoarthritis of the Knee
Johnson & Johnson Consumer and Personal Products Worldwide12 个研究点 分布在 1 个国家目标入组 626 人开始时间: 2010年7月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 626
- 试验地点
- 12
- 主要终点
- Pain Score
研究概览
简要总结
An evaluation of the safety and efficacy of an herbal patch in treating osteoarthritis pain of the right or left knee.
详细描述
This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study of herbal patch in subjects with OA knee pain. The overall objective of this study is to evaluate the efficacy and safety of the patch in relieving OA knee 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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 40 and 70 years of age
- •Medically cleared to participate by a site affiliated physician following a physical
- •History of, or current diagnosis of, OA of the knee
- •Evidence of idiopathic OA of at least one knee
- •Subject Assessment of OA pain in target knee 40 - 75 mm (on the 100 mm VAS inclusive) in the index knee, on the WOMAC Pain composite subscale at Visit 1
- •Subject Assessment of OA pain in non-index knee (if applicable) is ≤ 20mm
- •Subject Global Assessment of OA Condition (5 pt categorical scale, 1 = very good to 5 = very poor) of grade 3-5 (i.e. fair, poor or very poor)
- •Evidence of idiopathic OA of at least one knee as defined by the American College of Rheumatology Classification (ACR) of OA of the Knee
排除标准
- •Grade 1 or Grade 4 severity of the index knee based on the Kellgren and Lawrence radiographic criteria
- •Pain greater than 20 mm on the VAS in the non-index knee (either at rest or with movement)
- •Prior injection or arthroscopy of study knee within 3 months
- •Crystalline-induced synovitis (e.g. gout, pseudo gout, nonsteroid arthritis, hydroxyapatite deposit), acute inflammatory arthritis, rheumatoid arthritis, psoriatic arthritis, septic arthritis, fibromyalgia, systemic lupus, erythematosus collagen vascular disease or other types of inflammatory arthritis in the index knee
- •Pain in either knee is of neurological origin
- •An injury or surgery to the same body region within the prior 6 months or a lifetime history of 3 or more injuries/surgeries to the injured body region
- •Signs of clinically important active inflammation of the study knee joint including redness, warmth, and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits
- •Other criteria that - in the opinion of the investigator - may jeopardize the safety of the subject or the study results.
结局指标
主要结局
Pain Score
时间窗: Day 7
The WOMAC (Western Ontario and McMaster Universities Index of Osteoarthritis) Pain Subscale Score
次要结局
- Subject Assessment(Day 14)
- Investigator Assessment(Day 14)
研究者
研究点 (12)
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