NCT01496326已完成2 期
A Pilot Study to Compare the Efficacy and Safety of a Novel 10% Ibuprofen Formulation Versus Placebo Alone Applied to the Knee in Patients With Painful Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS) Pain scale
研究概览
简要总结
This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment of ibuprofen compared to the use of a placebo topical treatment.
A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days Dosing twice daily (b.i.d.)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged at least 40 years.
- •Primary osteoarthritis in a single knee joint, grade II/III based on the Kellgren and Lawrence classification system.
- •Radiographic evidence consistent with osteoarthritis carried out within 6 months before screening.
- •pain is currently not adequately controlled with a simple analgesic or an NSAID OR would necessitate treatment, but is not yet treated.
排除标准
- •Concomitant presence of another type of continuous pain that is more severe in intensity in comparison with the osteoarthritis target joint pain
- •Osteoarthritis causing significant pain in any joint other than the identified knee, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at visit 1 for any other painful joint concerned.
- •Female patients who are pregnant or breast-feeding.
研究组 & 干预措施
Ibuprofen
Experimental
干预措施: Ibuprofen (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS) Pain scale
时间窗: 14 days
次要结局
未报告次要终点
研究者
研究点 (1)
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