A Randomized, Double-blind, Placebo-controlled, Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects Experiencing Acute Delayed Onset Muscle Soreness (DOMS) of the Lower Limbs
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.
研究概览
简要总结
This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with DOMS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 18-35 years
- •Not engaged in regular lower extremity fitness activities in the past 6 months prior to screening
- •Willing to refrain from use of ice, heat and massage during the study
- •DOMS score ≥4 Pain at Rest (PAR) and a DOMS score ≥5 Pain on Walking (POW), with moderate or severe on categorical scale
排除标准
- •Pain medication & corticosteroids prior to randomization
- •Topical analgesic or anti-inflammatory treatment over the previous month
- •Body mass index of >32 kg/m2
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo gel applied four times daily
干预措施: Diclofenac sodium gel 1% (Drug)
diclofenac sodium gel 1%
diclofenac sodium gel 1% applied four times daily
干预措施: Diclofenac sodium gel 1% (Drug)
diclofenac sodium gel 1%
diclofenac sodium gel 1% applied four times daily
干预措施: Placebo (Drug)
Placebo
Placebo gel applied four times daily
干预措施: Placebo (Drug)
结局指标
主要结局
Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.
时间窗: 24 hours
The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the modified ITT population. SPID 24 derived from Pain on Walking (POW) scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ \[T(i) - T(i-1)\] x \[((PID)(i-1) + PID(i))/2\] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i.
次要结局
- Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW.(48 hours)