Acute Tendonitis, Bursitis
Conditions
Keywords
tendonitis and/or bursitis of the shoulder, acute tendonitis and/or bursitis of the shoulder
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 Tendonitis and Bursitis of the Shoulder.
Interventions
DRUGMRX-7EAT
Application of up to two patches for up to 7 days.
DRUGPlacebo
Application of up to two patches for up to 7 days.
Sponsors
MEDRx USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean of all 24 Current Pain Intensity scores collected on Days 2 through 7 on a 0-10 NPRS. | 7 days |
Countries
United States
Outcome results
None listed