Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02695381
Recruitment Status : Completed
First Posted : March 1, 2016
Last Update Posted : September 12, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Delayed Onset Muscle Soreness (DOMS) Drug: Etodolac-lidocaine topical patch Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Etodolac-lidocaine Topical Patch
Therapy with experimental drug
Drug: Etodolac-lidocaine topical patch
Once daily
Other Name: Etoreat

Placebo Comparator: Placebo
Therapy with placebo
Drug: Placebo
Once daily




Primary Outcome Measures :
  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). [ Time Frame: 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695381


Locations
Layout table for location information
United States, California
Lotus Clinical Research
Pasadena, California, United States, 91195
Sponsors and Collaborators
MEDRx USA, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Paulette Saddler, MD Lotus Clinical Research, LLC

Layout table for additonal information
Responsible Party: MEDRx USA, Inc.
ClinicalTrials.gov Identifier: NCT02695381     History of Changes
Other Study ID Numbers: MRX-7EAT-1010
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuromuscular Diseases
Lidocaine
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Etodolac
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors