NCT01335724已完成4 期
A Randomized, Double-blind, Placebo-controlled, Multi-center Parallel Group Phase IV Study to Evaluate the Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 72
- 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 and safety of diclofenac 1.16% gel compared with placebo applied four times a day in subjects with acute neck pain.
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
- •Male or female subjects, age range 18 and over.
- •Patient with acute neck pain meeting baseline pain intensity level and duration
排除标准
- •Pain medication was taken within the 6 hours that precede randomization.
- •Patient with chronic neck pain as defined as pain for 3 months or longer
- •Any neck pain that is attributable to any organic disease, such as prolapsed disc, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumors.
- •Any recent strains of the neck muscles documented by the clinical evaluation and anamnesis
研究组 & 干预措施
Diclofenac diethylamine 1.16% gel
Experimental
干预措施: Diclofenac diethylamine 1.16% gel (Drug)
placebo gel
Placebo Comparator
干预措施: Placebo gel (Drug)
结局指标
主要结局
Pain on Movement
时间窗: 48 h
Pain on movement on a 100 mm visual analog scale. Minimum score =0 mm "no pain". Maximum score =100 mm "extreme pain".
次要结局
- Pain at Rest(96h)
- Neck Disability Index(96h)
研究者
研究点 (1)
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