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

NCT02695381 | Completed Phase 3

• 1 other identifier: MRX-7EAT-1010
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Delayed Onset Muscle Soreness (DOMS)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Etodolac-lidocaine Topical Patch

EXPERIMENTAL

Therapy with experimental drug

Drug: Etodolac-lidocaine topical patch

Placebo

PLACEBO COMPARATOR

Therapy with placebo

Drug: Placebo

Interventions

Etodolac-lidocaine topical patch DRUG

Once daily

Also known as: Etoreat

Etodolac-lidocaine Topical Patch

Placebo DRUG

Once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MEDRx USA, Inc.: lead

Study Sites (1)

Lotus Clinical Research

Pasadena, California, 91195, United States

Location

Study Officials

• Paulette Saddler, MD

  Lotus Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 1, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 12, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)