Safety & Efficacy Study of MRX-7EAT Patch in the Treatment of Pain of the Shoulder
Information source: IL Pharma Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bursitis; Tendonitis; Shoulder Pain
Intervention: MRX-7EAT (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: IL Pharma Inc. Official(s) and/or principal investigator(s): Yuji Kuwabara, Study Chair, Affiliation: IL Pharma
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Mean of all 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS.
Eligibility
Minimum age: 14 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Birmingham, Alabama 35216, United States
Scottsdale, Arizona 85258, United States
Los Angels, California 90036, United States
San Diego, California 92120, United States
Denver, Colorado 80239, United States
Clearwater, Florida 33761, United States
Coral Gables, Florida 33134, United States
Fort Lauderdale, Florida 33136, United States
Kissimmee, Florida 34741, United States
Lauderdale Lakes, Florida 33319, United States
Miami, Florida 33155, United States
Orlando, Florida 32804, United States
Boise, Idaho 83702, United States
Lexington, Kentucky 40504, United States
Marrero, Louisiana 70072, United States
Southfield, Michigan 48034, United States
Raleigh, North Carolina 27612, United States
Fargo, North Dakota 58103, United States
Zanesville, Ohio 43701, United States
Gresham, Oregon 97030, United States
Altoona, Pennsylvania 16602, United States
Charleston, South Carolina 29412, United States
Dallas, Texas 75254, United States
El Paso, Texas 79902, United States
San Antonio, Texas 78207, United States
San Antonio, Texas 78229, United States
Temple, Texas 76502, United States
Additional Information
Starting date: December 2011
Last updated: October 24, 2012
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