MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder

A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder

A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder.

Study Overview

• Status: Completed
• Conditions: Bursitis; Acute Tendonitis
• Intervention / Treatment: Drug: Placebo; Drug: MRX-7EAT

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
    • Phoenix, Arizona, United States, 85050
  • Arkansas
    • North Little Rock, Arkansas, United States, 72114
  • California
    • Chico, California, United States, 95929
    • Mission Hills, California, United States, 91345
    • Palm Springs, California, United States, 92262
    • San Diego, California, United States, 92120
  • Colorado
    • Aurora, Colorado, United States, 80014
    • Colorado Springs, Colorado, United States, 80907
    • Denver, Colorado, United States, 80239
  • Florida
    • Daytona Beach, Florida, United States, 32114
    • Fort Lauderdale, Florida, United States, 33334
    • Gulf Breeze, Florida, United States, 32561
    • Orlando, Florida, United States, 32804
    • West Palm Beach, Florida, United States, 33409
  • Indiana
    • Avon, Indiana, United States, 46123
    • Fishers, Indiana, United States, 46038
    • Franklin, Indiana, United States, 46131
    • Greenfield, Indiana, United States, 46140
    • Muncie, Indiana, United States, 47304
  • Iowa
    • Dubuque, Iowa, United States, 52002
    • Dubuque, Iowa, United States, 52001
  • Kansas
    • Wichita, Kansas, United States, 67206
  • Kentucky
    • Erlanger, Kentucky, United States, 41018
  • Nevada
    • Henderson, Nevada, United States, 89052
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
  • North Dakota
    • Fargo, North Dakota, United States, 58103
  • Ohio
    • Cincinnati, Ohio, United States, 45246
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
  • Texas
    • Georgetown, Texas, United States, 78626
    • Lubbock, Texas, United States, 79410
    • San Antonio, Texas, United States, 78229
    • Temple, Texas, United States, 76502
  • Utah
    • Riverton, Utah, United States, 84065
  • Virginia
    • Danville, Virginia, United States, 24541

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

• Subject is 14 years of age or older (with assent according to state law).
• Females of child bearing potential must have a negative pregnancy test.
• Subject has a diagnosis of acute tendonitis or bursitis of one shoulder with the onset of the current episode 5 days and ≤ 21 days preceding the screening visit. Diagnosis is indicated by a positive Hawkins Test and Neer Test, both resulting in pain with motion and the existence of shoulder impingement related to tendonitis or bursitis.
• Subject has a Current Pain Intensity rated prior to study entry ≥ 5 but ≤ 8 on a Numeric Pain Rating Scale (NPRS) (11 point; range 0 to 10; anchors to be "none" and "severe").

Main Exclusion Criteria:

• Subject has a suspected tear in the rotator cuff, calcific tendonitis.
• Standard of Care (SOC) diagnosis with an AP and lateral x-ray, adhesive capsulitis, shoulder fractures, bilateral tendonitis or bursitis of the shoulders; or orthopedic surgical treatment is required.
• Subject has a positive Drop Arm Test indicative of a suspected tear; a positive O'Brien's Test suggestive of a glenoid labral tear; a positive Apprehension Test which would be indicative of glenohumeral instability.
• Subject had a previous episode of shoulder pain in the same area within two months.
• Subject received passive physical therapy treatments (e.g., deep heat or ultrasound) for the tendonitis/bursitis for the target shoulder within the past 24 hours; requires continued use of an immobilization device for treatment of the current episode of tendonitis or bursitis or use of iontophoresis.
• Subject has used oral pharmacologic treatment (NSAIDs or analgesic medications) less than 3 half-lives before the baseline assessments; ibuprofen is permitted prior to baseline as long as it is not within 6 hours of the baseline assessment.
• Subject has used any form of opioid within 24 hours of study entry or use of opioids for 5 or more consecutive days within the 30 days preceding enrollment.
• Subject has received systemic corticosteroids in the 30 days preceding the screening visit.
• Subject recently initiated sleep medications, muscle relaxants, anticonvulsants or antidepressants.
• Subject used TNF alpha blockers or Class 1 anti-arrhythmic drugs within the past 60 days.
• Subject has a history or physical assessment finding of clinically significant.
• GI ulcers or abnormal bleeding, anemia, kidney disease, liver disease, poorly controlled lung, stomach, heart, or other vital organ disease as determined by the study investigator/physician.
• Subject has a history or physical assessment finding that is not compatible with safe participation in the study.
• Subject has a pain or medical problem that in the investigator's opinion may interfere with pain measurement of the target joint.
• Subject has active skin lesions or disease at the intended site of application of the study medication.
• Subject has a history of allergy to etodolac, other NSAIDs, lidocaine or adhesives (e.g., adhesive tape).
• Subject has a history of prior failed treatment with topical NSAIDs.
• Subject has a history of drug or alcohol abuse.
• Subject received an investigational drug within a period of 30 days prior to receiving study medication.
• Subject is scheduled for elective surgery or other invasive procedures during the period of study participation.
• Subject is on workman's compensation or has pending legal hearings.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Therapy with placebo	Drug: Placebo; Application of up to two patches for up to 7 days.
Experimental: MRX-7EAT; Therapy with experimental drug	Drug: MRX-7EAT; Application of up to two patches for up to 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean of all 24 Current Pain Intensity scores collected on Days 2 through 7 on a 0-10 NPRS.	7 days

Collaborators and Investigators

• Sponsor: MEDRx USA, Inc.
• Investigators: Study Chair: Martine Francis, IL Pharma

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 12, 2010
• First Submitted That Met QC Criteria: July 12, 2010
• First Posted (Estimate): July 13, 2010

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 14, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: tendonitis and/or bursitis of the shoulder; acute tendonitis and/or bursitis of the shoulder
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Bursitis
• Other Study ID Numbers: MRX-7EAT-1006