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

Phase 3

Completed

• Conditions: Acute Delayed Onset Muscle Soreness (DOMS)
• Interventions: Drug: Placebo; Drug: Etodolac-lidocaine topical patch

• Registration Number: NCT02695381
• Lead Sponsor: MEDRx USA, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-29
• Study Start: 2016-03
• Study First Posted: 2016-03-01
• Primary Completion: 2016-08
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Therapy with placebo
Etodolac-lidocaine Topical Patch	Etodolac-lidocaine topical patch	Therapy with experimental drug

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lotus Clinical Research; 🇺🇸 Pasadena, California, United States