Etodolac-lidocaine Patch in Subjects Experiencing Acute Delayed Onset Muscle Soreness

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Delayed Onset Muscle Soreness (DOMS)

Intervention / Treatment
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* Drug: Etodolac-lidocaine topical patch
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etodolac-lidocaine Topical Patch<br>Therapy with experimental drug | Drug: Etodolac-lidocaine topical patch<br>* Once daily<br>* Other names: Etoreat;|
| Placebo Comparator: Placebo<br>Therapy with placebo | Drug: Placebo<br>* Once daily<br>|

What is the study measuring?
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Primary Outcome Measures

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