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 Soft Tissue Injuries
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 407
- 试验地点
- 1
- 主要终点
- Change in average pain during daily activity at Day 7
研究概览
简要总结
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing mild to moderate soft tissue injuries 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 mild to moderate soft tissue injuries.
Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the diclofenac topical patch or a matching placebo patch to be applied once daily for 14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a follow-up assessment will be conducted on Day 21. Patients will complete an electronic diary in which assessments including pain intensity and pain relief will be recorded twice daily. Functional disability and global impression of change will be recorded in the diary at study visits, ratings of the quality of sleep will 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 18-75 years of age
- •Sustained recent, painful unilateral mild to moderate soft tissue injury (between the mid-bicep to wrist or mid-thigh to ankle)
- •Meet baseline pain criterion
排除标准
- •Open wound or infection at site of injury
- •Evidence of severe injury, including fracture or nerve injury
- •Use of oral NSAIDs or opioids within 12-24 hours of injury
- •Presence or history of peptic ulcers or GI bleeding
- •A 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 (Drug)
Topical 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 at Day 7
时间窗: Day 7
次要结局
- Change in average pain during daily activity at Day 14(Day 14)