MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis 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: Acute Tendonitis; Bursitis
Intervention: MRX-7EAT (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: IL Pharma Inc. Official(s) and/or principal investigator(s): Martine Francis, 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 Tendonitis and 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 Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the 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 24 Current Pain Intensity scores collected on Days 2 through 7 on a 0-10 NPRS.
Eligibility
Minimum age: 14 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Chandler, Arizona 85224, United States
Phoenix, Arizona 85050, United States
North Little Rock, Arkansas 72114, United States
Chico, California 95929, United States
Mission Hills, California 91345, United States
Palm Springs, California 92262, United States
San Diego, California 92120, United States
Aurora, Colorado 80014, United States
Colorado Springs, Colorado 80907, United States
Denver, Colorado 80239, United States
Daytona Beach, Florida 32114, United States
Ft. Lauderdale, Florida 33334, United States
Gulf Breeze, Florida 32561, United States
Orlando, Florida 32804, United States
West Palm Beach, Florida 33409, United States
Avon, Indiana 46123, United States
Fishers, Indiana 46038, United States
Franklin, Indiana 46131, United States
Greenfield, Indiana 46140, United States
Muncie, Indiana 47304, United States
Dubuque, Iowa 52001, United States
Dubuque, Iowa 52002, United States
Wichita, Kansas 67206, United States
Erlanger, Kentucky 41018, United States
Henderson, Nevada 89052, United States
Charlotte, North Carolina 28207, United States
Fargo, North Dakota 58103, United States
Cincinnati, Ohio 45246, United States
Oklahoma City, Oklahoma 73112, United States
Georgetown, Texas 78626, United States
Lubbock, Texas 79410, United States
San Antonio, Texas 78229, United States
Temple, Texas 76502, United States
Riverton, Utah 84065, United States
Danville, Virginia 24541, United States
Additional Information
Starting date: July 2010
Last updated: June 28, 2012
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