临床试验/NCT02695381

NCT02695381已完成3 期

A Randomized, Double-blind, Multiple-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of Etodolac-lidocaine Patch Applied Once Daily in Subjects Experiencing Acute Delayed Onset Muscle Soreness

MEDRx USA, Inc.1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2016年3月最近更新: 2016年9月12日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: MEDRx USA, Inc.
入组人数: 100
试验地点: 1
主要终点: Sum of the time-weighted differences from baseline in pain intensity with movement (SPIDMove) over 0-24 hours post-T0 (SPIDMove 0-24 hours).

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 evaluate the efficacy and safety of Etodolac-lidocaine topical patch applied one time daily when compared with placebo in the treatment of acute Delayed Onset Muscle Soreness (DOMS) of the upper limbs.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
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

•Have not engaged in significant upper extremity fitness activities for more than two times per week for ≥ 2 consecutive weeks in the past 6 months prior to screening.
•Subject has a body mass index of between 18 and 30 kg/m2, inclusive.
•Subjects who report a pain with movement score in both arms of at least 5 (based on a 0-10 NRS) secondary to DOMS approximately 24 to 30 hours after each arm was exercised.

排除标准

•Presence of another painful physical condition that, in the opinion of the Investigator, may confound study assessments.
•Use of pain medication (including anti-inflammatory drugs) prior to the Exercise Visit until 72 hours after randomization.
•Use of any corticosteroids (oral, injectable, topical, inhaled) from before the Exercise Visit until randomization. Corticosteroids must be washed out by at least 3 days before the Exercise Visit.
•Chronic or acute renal or hepatic disorder, inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or a significant coagulation defect.
•History of allergy (cutaneous or systemic), asthma, hypersensitivity to any of the following: etodolac, lidocaine, paracetamol (acetaminophen), acetylsalicylic acid, salicylic acid, other NSAID, other local anesthetic, known intolerance (cutaneous or systemic) to any of the ingredients in the patch.

研究组 & 干预措施

Etodolac-lidocaine Topical Patch

Experimental

Therapy with experimental drug

干预措施: Etodolac-lidocaine topical patch (Drug)

Placebo

Placebo Comparator

Therapy with placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Sum of the time-weighted differences from baseline in pain intensity with movement (SPIDMove) over 0-24 hours post-T0 (SPIDMove 0-24 hours).

时间窗: 24 hours

次要结局

未报告次要终点

研究者

发起方

MEDRx USA, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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