NCT00955513已完成3 期
A Randomized, Double-blind, Multi-center, Placebo-controlled, 3-treatment Arm, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
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
- 242
- 试验地点
- 1
- 主要终点
- Measure: Pain on Movement on Day 5 (Change From Baseline).
研究概览
简要总结
The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute sprain of the lateral ankle, Grade I-II .
排除标准
- •Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
- •Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.
研究组 & 干预措施
diclofenac diethylamine gel 2.32% gel twice a day
Experimental
drug
干预措施: diclofenac diethylamine gel 2.32% (Drug)
diclofenac diethylamine gel 2.32% gel three times a day
Experimental
drug
干预措施: diclofenac diethylamine gel 2.32% (Drug)
placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Measure: Pain on Movement on Day 5 (Change From Baseline).
时间窗: baseline and day 5
Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.
次要结局
未报告次要终点
研究者
研究点 (1)
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