Clinical trial NCT01161615: MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Tendonitis
Bursitis
Keywords: tendonitis and/or bursitis of the shoulder
acute tendonitis and/or bursitis of the shoulder
Lead sponsor: MEDRx USA, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-13
Enrollment: 350
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean of all 24 Current Pain Intensity scores collected on Days 2 through 7 on a 0-10 NPRS.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: North Little Rock
country: United States
state: Arkansas
city: Chico
country: United States
state: California
city: Mission Hills
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Daytona Beach
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Gulf Breeze
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Avon
country: United States
state: Indiana
city: Fishers
country: United States
state: Indiana
city: Franklin
country: United States
state: Indiana
city: Greenfield
country: United States
state: Indiana
city: Muncie
country: United States
state: Indiana
city: Dubuque
country: United States
state: Iowa
city: Dubuque
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Erlanger
country: United States
state: Kentucky
city: Henderson
country: United States
state: Nevada
city: Charlotte
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Georgetown
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Riverton
country: United States
state: Utah
city: Danville
country: United States
state: Virginia
Study officials:
affiliation: IL Pharma
name: Martine Francis
role: STUDY_CHAIR
References: