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

MEDRx

Status and phase

Completed

Phase 3

Conditions

Acute Delayed Onset Muscle Soreness (DOMS)

Treatments

Drug: Placebo

Drug: Etodolac-lidocaine topical patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT02695381

MRX-7EAT-1010

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.