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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Tendonitis, Bursitis

Intervention / Treatment
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* Drug: MRX-7EAT
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tendonitis and/or bursitis of the shoulder, acute tendonitis and/or bursitis of the shoulder