临床试验/NCT02324985

NCT02324985已完成2 期

Phase II Study of the Effects of AP0302 5% (S-Ibuprofen Topical Gel 5%) Versus the Vehicle Control on Delayed Onset Muscle Soreness of the Elbow Flexors

Aponia Laboratories, Inc.1 个研究点分布在 1 个国家目标入组 147 人开始时间: 2015年1月最近更新: 2019年2月25日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Aponia Laboratories, Inc.
入组人数: 147
试验地点: 1
主要终点: Sum of pain intensity differences over 24 hours from baseline (SPID24) with movement

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness.

详细描述

The purpose of this study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).

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: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 35 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•no clinically significant medical conditions
•BMI between 18-30
•negative drug, alcohol, pregnancy screens
•other protocol-defined inclusion criteria may apply

排除标准

•no upper extremity workout in last 6 months
•no job requiring heavy lifting
•history of muscle disorders
•allergy or intolerance to study drug
•history of recent pain medication use
•other protocol-defined exclusion criteria may apply

研究组 & 干预措施

Active Arm

Active Comparator

S-Ibuprofen Topical Gel 5%

干预措施: S-Ibuprofen Topical Gel 5% (Drug)

Placebo Arm

Placebo Comparator

Vehicle Topical Gel

干预措施: Vehicle Topical Gel (Drug)

结局指标

主要结局

Sum of pain intensity differences over 24 hours from baseline (SPID24) with movement

时间窗: 0-24 hours

SPID 24

次要结局

Sum of pain intensity differences over 48 hours from baseline (SPID48) at rest(0-48 hours)
Sum of pain intensity differences over 48 hours from baseline (SPID48) with movement(0-48 hours)

研究者

发起方

Aponia Laboratories, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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