临床试验/NCT01255423

NCT01255423已完成3 期

A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain

Novartis0 个研究点目标入组 206 人开始时间: 2010年11月最近更新: 2012年10月4日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 206
主要终点: Pain on Movement

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four 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: Double (Participant, Investigator)

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

未提供

排除标准

未提供

研究组 & 干预措施

Diclofenac sodium topical gel 1%

Experimental

干预措施: Diclofenac sodium topical gel 1% (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Pain on Movement

时间窗: 72 hours

Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= "No pain" and 100= "Extreme pain"

次要结局

Pain on Movement(24 hours and 7 days)
Onset of Pain Relief(Day 1)
Tenderness(Change from baseline at 24 and 72 hours, 7 days)
Ankle Joint Function(24 and 72 hours, 7 days)

研究者

发起方

Novartis

申办方类型

Industry

责任方

Sponsor

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