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

Acute Delayed Onset Muscle Soreness (DOMS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695381
• Other study ID #: MRX-7EAT-1010
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2016
• Last updated: September 8, 2016
• Start date: March 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: MEDRx USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Delayed Onset Muscle Soreness (DOMS)
• Myalgia

Intervention

Drug:
• Etodolac-lidocaine topical patch
Once daily
• Placebo
Once daily

Locations

Country	Name	City	State
United States	Lotus Clinical Research	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
MEDRx USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes