A Clinical Study to Assess the Efficacy of Pain Relief of Topical Indomethacin Patch Over Placebo in Ankle Sprain Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 15
- 主要终点
- Sum of Pain Intensity Difference (SPID)1-3 Days
研究概览
简要总结
This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients, compared to a placebo patch
详细描述
Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which reduces pain, fever, stiffness and swelling in acute skeletal musculature injuries involving joints. However, oral Indomethacin formulations predisposes for some systemic side effects. To avoid the systemic side effects of oral Indomethacin, a topical Indomethacin formulations have been developed and approved in some countries as an Over the counter product. Present study is to investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant with Grade I or Grade II acute sprain of the lateral ankle within 24 hours before screening visit
- •Participant with self-assessed pain intensity score after movement (5 steps) at the site of the ankle sprain that is >= 5 as measured on a 0-10 NRS rating.
- •Participant with a peri-malleolar edema (sub-malleolar perimeter difference of >=20mm between injured and uninjured ankle)
排除标准
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •Participant who had medication that could interfere with the subject's perception of pain since experiencing ankle sprain.
- •Pregnancy , Breast Feeding and Substance Abuse
研究组 & 干预措施
Placebo patch
Placebo patch to be applied on the sprained ankle BID.
干预措施: Placebo (Drug)
Indomethacin patch
Indomethacin patch to be applied on the sprained ankle twice a day (BID).
干预措施: Indomethacin (Drug)
结局指标
主要结局
Sum of Pain Intensity Difference (SPID)1-3 Days
时间窗: Baseline (Day 1) to Day 3
SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs and 48 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1). Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents "No" and 10 represents the "worst possible pain"
次要结局
- Change From Baseline in NRS at Rest(Baseline (Day 1) to Day 7)
- Total Pain Relief (TOTPAR) on Movement(Baseline (Day 1) to Day 7)
- Time to First Dose of Rescue Medication Use(Baseline (Day 1) to Day 14)
- Pain Relief Score (PRS) on Movement Over Time(30 minutes (mins) to 144 hours (hrs) post treatment)
- NRS for Pain on Movement Over Time(30 mins to 144 hr post treatment)
- Time to Onset of Pain Relief(Baseline (Day 1) to Day 3)
- Assessment of Sum of Pain Intensity Difference (SPID) on Movement(Baseline (Day 1) to Day 7)
- Sum of Pain Intensity Difference and Pain Relief (SPRID) on Movement(Baseline (Day 1) to Day 7)
- Patients' Global Assessment to Treatment(Baseline (Day 1) to Day 14)
- Rate of Rescue Medication Use(Baseline (Day 1) to Day 14)
- Total Dose of Rescue Medication Use(Baseline (Day 1) to Day 14)