mrx-7eat etodolac-lidocaine topical patch in the treatment of tendonitis and bursitis of the shoulder

Conditions: Acute Tendonitis; Bursitis

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.


Eligibility 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.

Keywords: tendonitis and/or bursitis of the shoulder acute tendonitis and/or bursitis of the shoulder