A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Change in average pain during daily activity
研究概览
简要总结
The purpose of the study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate wrist sprain, strain or contusion when applied to the painful area.
详细描述
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with a mild to moderate wrist sprain, strain or contusion.
Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment to either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice daily. Ratings of the quality of sleep will also be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.
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
- 17 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 17 - 75 years of age
- •Sustained recent, painful unilateral mild to moderate wrist sprain, strain or contusion
- •Meet baseline pain criterion
排除标准
- •Open wound or infection at the site of injury
- •Severe wrist injury or wrist fracture
- •Presence or history of hand, wrist or forearm nerve impingement or palsies
- •Use of NSAIDs or opioids within 12 - 24 hours of wrist injury
- •Presence or history of peptic ulcers or GI bleeding
- •History of intolerance to NSAIDs, acetaminophen, adhesives
- •Positive pregnancy test
- •Positive drug screen
研究组 & 干预措施
Diclofenac Sodium Patch
干预措施: Diclofenac Sodium Patch (Drug)
Placebo Patch
干预措施: Matching Placebo Patch (Drug)
结局指标
主要结局
Change in average pain during daily activity
时间窗: Day 3
次要结局
- Change in average pain during daily activity(Day 7)