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.

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.