The Efficacy and Safety of an Esflurbiprofen Hydrogel Patch vs. Placebo in the Local Symptomatic and Short-term Treatment of Pain in Acute Strains, Sprains or Bruises of the Extremities Following Blunt Trauma, e.g. Sports Injuries.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change of Pain-on-movement (POM) Compared to Baseline
研究概览
简要总结
Objective of this study is:
to determine efficacy and safety of a Esflurbiprofen Hydrogel Patch compared to placebo in patients with acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries.
to demonstrate that the Esflurbiprofen Hydrogel Patch is superior to placebo, and that the patch has acceptable local tolerability.
详细描述
Study Design Randomized (1:1) (stratified by center and 2 subgroups), controlled, double-blind, multi-centric study in parallel groups. Patient Population/Sample size/Study Sites
The clinical trial population will consist of male or female patients, 18 - 60 years suffering from acute; strains, sprains or bruises of the extremities following blunt trauma, and meeting all clinical trial entry criteria.
200 patients will be enrolled (assumes a drop-out-rate of ≤10%).
The study will be performed in Germany in 3 sites
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)
盲法说明
Packages of Investigative Medicinal product will be non-distinguishable to patients, study site staff and monitors.
Randomization data are kept strictly confidential, accessible only to authorized persons, until the time of unblinding the identity of the treatments will be concealed by the use of study drugs that are all identical in packaging, labeling, schedule of administration, appearance and odor.
Unblinding will only occur in the case of patient emergencies and at the conclusion of the study.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Active Arm
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
干预措施: Esflurbiprofen Hydrogel Patch (Drug)
Control Drug
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
干预措施: Esflurbiprofen Hydrogel Patch (Drug)
结局指标
主要结局
Change of Pain-on-movement (POM) Compared to Baseline
时间窗: Change from baseline to Visit 5 (72 hours after initiating treatment)
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
次要结局
- Pain-on-movement (POM) on VAS(Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment)
- Area-under-the-curve for POM on VAS(Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment)
- Pain-at-rest on VAS(Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment)
- Time to Meaningful and Optimal Reduction(Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment)
- Time to Complete Resolution of Pain(Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment)
- Responder Rate 1(72 hours)
- Resolution of Soft Tissue Injury/Contusion(168h)
- SPID of POM VAS Changes(0-24 h, 0-48 h, 0-72 h, and 0-96 h)
- Responder Rate 2 at 168h(168h)
- Global Efficacy Assessments 1 by Patient(48 h, 72 h, and 168 h)
- Global Efficacy Assessments 1 by Investigator(48 h, 72 h, and 168 h)
- Global Efficacy Assessments 2 by Patient(48 h, 72 h, and 168 h)
- Use of Rescue Medication(0-168h)