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

September 8, 2016 updated by: MEDRx USA, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91195
        • Lotus Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Etodolac-lidocaine Topical Patch
Therapy with experimental drug
Drug: Etodolac-lidocaine topical patch
Once daily
Other Names:
  • Etoreat
PLACEBO_COMPARATOR: Placebo
Therapy with placebo
Drug: Placebo
Once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MEDRx USA, Inc.

Investigators

  • Principal Investigator: Paulette Saddler, MD, Lotus Clinical Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (ESTIMATE)

March 1, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 12, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRX-7EAT-1010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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