Clinical trial NCT01506154: Safety & Efficacy Study of MRX-7EAT Patch in the Treatment of Pain 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 Topical Patch in the Treatment of Pain Due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of Shoulder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bursitis
Tendonitis
Shoulder Pain
Keywords: bursitis/tendonitis and/or subdeltoid bursitis
Lead sponsor: MEDRx USA, Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-09
Enrollment: 210
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 Pain due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of the Shoulder.


Eligibility criteria: Inclusion Criteria:

* Females of child bearing potential must have a negative pregnancy test and be using an adequate method of birth control.
* Subject has a diagnosis of acute supraspinatous or subacromial bursitis/tendonitis and/or subdeltoid bursitis of one shoulder with the onset of the current episode ≥ 24 hours and ≤ 7 days preceding the screening visit.
* Subject has a Current Pain Intensity rated prior to study entry ≥ 6 but ≤ 8 on a Numeric Pain Rating Scale (NPRS).

Exclusion Criteria:

* Subject has a suspected tear in the rotator cuff, calcific tendonitis, adhesive capsulitis, shoulder fractures, bilateral shoulder pain, bilateral tendonitis and/or bursitis of the shoulders, bicipital tendonitis; 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; a positive Yergason's Test which would be indicative of bicipital tendonitis.
* Subject had a previous episode of shoulder pain in the same area within two weeks prior to the current episode; history of chronic pain in the target shoulder; history of rotator cuff injury or previous surgery in the same area.
* Subject received passive physical therapy treatments for the pain in the target shoulder within the past 24 hours.
* Subject has used oral pharmacologic treatment less than 5 half-lives before the baseline assessments.
* 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; or local injections such as intra-articular, bursal, peritendinous; topical corticosteroids are acceptable unless applied to the target joint; and inhaled or intranasal steroids acceptable (e.g., Flonase®).
* Subject recently initiated sleep medications, muscle relaxants, anticonvulsants or antidepressants (within the past 30 days).
* 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 fibromyalgia, spondyloarthropathies (SpA) or other systemic arthritis such as rheumatoid arthritis. Arthritis typically localized such as gout or osteoarthritis is acceptable as long as it does not affect the injured area.
* Subject has a painful syndrome (e.g. sciatica) or cervical spine disorder leading to a nerve entrapment syndrome or other 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 study medication application, which may be covered by the patch. Skin lesions include open wounds, rash, papules and vesicles; abrasions, lacerations or any break in skin.
* Subject has a history of allergy to etodolac, other NSAIDs, lidocaine or adhesives (e.g., adhesive tape).
* Subject is scheduled for elective surgery or other invasive procedures during the period of study participation.

Primary outcomes:
measure: Mean of all 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Clearwater
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Lexington
country: United States
state: Kentucky
city: Marrero
country: United States
state: Louisiana
city: Southfield
country: United States
state: Michigan
city: Raleigh
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Zanesville
country: United States
state: Ohio
city: Gresham
country: United States
state: Oregon
city: Altoona
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Temple
country: United States
state: Texas
Study officials:
affiliation: IL Pharma
name: Yuji Kuwabara
role: STUDY_CHAIR
References: