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

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. Identifier: NCT01506154
Recruitment Status : Completed
First Posted : January 9, 2012
Last Update Posted : January 16, 2018
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bursitis Tendonitis Shoulder Pain Drug: MRX-7EAT Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bursitis
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Mean of all 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS. [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01506154

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States, 35216
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, California
Los Angeles, California, United States, 90036
San Diego, California, United States, 92120
United States, Colorado
Denver, Colorado, United States, 80239
United States, 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
United States, Idaho
Boise, Idaho, United States, 83702
United States, Kentucky
Lexington, Kentucky, United States, 40504
United States, Louisiana
Marrero, Louisiana, United States, 70072
United States, Michigan
Southfield, Michigan, United States, 48034
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Zanesville, Ohio, United States, 43701
United States, Oregon
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Altoona, Pennsylvania, United States, 16602
United States, South Carolina
Charleston, South Carolina, United States, 29412
United States, Texas
Dallas, Texas, United States, 75254
El Paso, Texas, United States, 79902
San Antonio, Texas, United States, 78207
San Antonio, Texas, United States, 78229
Temple, Texas, United States, 76502
Sponsors and Collaborators
Study Chair: Yuji Kuwabara IL Pharma

Responsible Party: MEDRx USA, Inc. Identifier: NCT01506154     History of Changes
Other Study ID Numbers: MRX-7EAT-2006
First Posted: January 9, 2012    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: October 2012

Keywords provided by MEDRx USA, Inc.:
bursitis/tendonitis and/or subdeltoid bursitis

Additional relevant MeSH terms:
Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Tendon Injuries
Wounds and Injuries