Safety & Efficacy Study of MRX-7EAT Patch in the Treatment of Pain of the Shoulder

A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Topical Patch in the Treatment of Pain Due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of 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 Pain due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of the Shoulder.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
  • Arizona
    • Scottsdale, Arizona, United States, 85258
  • California
    • Los Angeles, California, United States, 90036
    • San Diego, California, United States, 92120
  • Colorado
    • Denver, Colorado, United States, 80239
  • Florida
    • Clearwater, Florida, United States, 33761
    • Coral Gables, Florida, United States, 33134
    • Fort Lauderdale, Florida, United States, 33136
    • Kissimmee, Florida, United States, 34741
    • Lauderdale Lakes, Florida, United States, 33319
    • Miami, Florida, United States, 33155
    • Orlando, Florida, United States, 32804
  • Idaho
    • Boise, Idaho, United States, 83702
  • Kentucky
    • Lexington, Kentucky, United States, 40504
  • Louisiana
    • Marrero, Louisiana, United States, 70072
  • Michigan
    • Southfield, Michigan, United States, 48034
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
  • North Dakota
    • Fargo, North Dakota, United States, 58103
  • Ohio
    • Zanesville, Ohio, United States, 43701
  • Oregon
    • Gresham, Oregon, United States, 97030
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
  • South Carolina
    • Charleston, South Carolina, United States, 29412
  • Texas
    • Dallas, Texas, United States, 75254
    • El Paso, Texas, United States, 79902
    • San Antonio, Texas, United States, 78229
    • San Antonio, Texas, United States, 78207
    • Temple, Texas, United States, 76502

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Females of child bearing potential must have a negative pregnancy test and be using an adequate method of birth control.
• Subject has a diagnosis of acute supraspinatous or subacromial bursitis/tendonitis and/or subdeltoid bursitis of one shoulder with the onset of the current episode ≥ 24 hours and ≤ 7 days preceding the screening visit.
• Subject has a Current Pain Intensity rated prior to study entry ≥ 6 but ≤ 8 on a Numeric Pain Rating Scale (NPRS).

Exclusion Criteria:

• Subject has a suspected tear in the rotator cuff, calcific tendonitis, adhesive capsulitis, shoulder fractures, bilateral shoulder pain, bilateral tendonitis and/or bursitis of the shoulders, bicipital tendonitis; 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; a positive Yergason's Test which would be indicative of bicipital tendonitis.
• Subject had a previous episode of shoulder pain in the same area within two weeks prior to the current episode; history of chronic pain in the target shoulder; history of rotator cuff injury or previous surgery in the same area.
• Subject received passive physical therapy treatments for the pain in the target shoulder within the past 24 hours.
• Subject has used oral pharmacologic treatment less than 5 half-lives before the baseline assessments.
• 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; or local injections such as intra-articular, bursal, peritendinous; topical corticosteroids are acceptable unless applied to the target joint; and inhaled or intranasal steroids acceptable (e.g., Flonase®).
• Subject recently initiated sleep medications, muscle relaxants, anticonvulsants or antidepressants (within the past 30 days).
• 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 fibromyalgia, spondyloarthropathies (SpA) or other systemic arthritis such as rheumatoid arthritis. Arthritis typically localized such as gout or osteoarthritis is acceptable as long as it does not affect the injured area.
• Subject has a painful syndrome (e.g. sciatica) or cervical spine disorder leading to a nerve entrapment syndrome or other 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 study medication application, which may be covered by the patch. Skin lesions include open wounds, rash, papules and vesicles; abrasions, lacerations or any break in skin.
• Subject has a history of allergy to etodolac, other NSAIDs, lidocaine or adhesives (e.g., adhesive tape).
• Subject is scheduled for elective surgery or other invasive procedures during the period of study participation.

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: MRX-7EAT; Once daily application of a patch for 14 days
Experimental: MRX-7EAT; Therapy with experimental drug	Drug: MRX-7EAT; Once daily application of a patch for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean of all 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS.	7 days

Collaborators and Investigators

• Sponsor: MEDRx USA, Inc.
• Investigators: Study Chair: Yuji Kuwabara, IL Pharma

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: January 5, 2012
• First Submitted That Met QC Criteria: January 5, 2012
• First Posted (Estimate): January 9, 2012

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: bursitis/tendonitis and/or subdeltoid bursitis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Arthralgia; Tendinopathy; Shoulder Pain; Bursitis
• Other Study ID Numbers: MRX-7EAT-2006