NCT00573768已完成2 期
A Randomized, Double-blind, Multi-center, Vehicle-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Once or Twice Daily in Patients With Acute Ankle Sprain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.
研究概览
简要总结
This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute sprain of the ankle
- •Injury within past 48 hours.
排除标准
- •Pain medication taken since the injury
- •Pain or instability in the same ankle due to previous ankle sprain or any other trauma.
- •Ankle sprain due to a known disease affecting the ligaments
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Active Comparator
干预措施: Diclofenac diethylamine 2.32% gel (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
3
Active Comparator
干预措施: Diclofenac diethylamine 2.32% gel / Placebo (Drug)
结局指标
主要结局
Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.
时间窗: change from baseline (on day 1) to day 5
Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)
次要结局
未报告次要终点
研究者
研究点 (1)
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