Safety & Efficacy Study of MRX-7EAT Patch in the Treatment of Pain of the Shoulder (NCT01506154) | Clinical Trial Compass
CompletedPhase 3
Safety & Efficacy Study of MRX-7EAT Patch in the Treatment of Pain of the Shoulder
United States210 participantsStarted 2011-12
Plain-language 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.
Who can participate
Age range14 Years
SexALL
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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…
What they're measuring
1
Mean of all 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS.