NCT01666197已完成4 期
A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain on Movement
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years and over.
- •Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.
- •Injury within past 12 hours.
排除标准
- •Pain medication was taken within the 6 hours that precede randomization.
- •During the past 3 months: Grade I-III sprain of the same ankle.
- •During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.
- •Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
- •Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
研究组 & 干预措施
diclofenac potassium 25 mg tablet
Experimental
干预措施: diclofenac potassium 25 mg tablet (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Pain on Movement
时间窗: 48 hours
Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"
次要结局
未报告次要终点
研究者
研究点 (1)
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