MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder
NCT ID: NCT01161615
Last Updated: 2018-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
350 participants
INTERVENTIONAL
2010-07-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Therapy with placebo
Placebo
Application of up to two patches for up to 7 days.
MRX-7EAT
Therapy with experimental drug
MRX-7EAT
Application of up to two patches for up to 7 days.
Interventions
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MRX-7EAT
Application of up to two patches for up to 7 days.
Placebo
Application of up to two patches for up to 7 days.
Eligibility Criteria
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Inclusion Criteria
* 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").
Exclusion Criteria
* 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.
14 Years
ALL
No
Sponsors
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MEDRx USA, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Martine Francis
Role: STUDY_CHAIR
IL Pharma
Locations
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Chandler, Arizona, United States
Phoenix, Arizona, United States
North Little Rock, Arkansas, United States
Chico, California, United States
Mission Hills, California, United States
Palm Springs, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Daytona Beach, Florida, United States
Fort Lauderdale, Florida, United States
Gulf Breeze, Florida, United States
Orlando, Florida, United States
West Palm Beach, Florida, United States
Avon, Indiana, United States
Fishers, Indiana, United States
Franklin, Indiana, United States
Greenfield, Indiana, United States
Muncie, Indiana, United States
Dubuque, Iowa, United States
Dubuque, Iowa, United States
Wichita, Kansas, United States
Erlanger, Kentucky, United States
Henderson, Nevada, United States
Charlotte, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Georgetown, Texas, United States
Lubbock, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Riverton, Utah, United States
Danville, Virginia, United States
Countries
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Other Identifiers
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MRX-7EAT-1006
Identifier Type: -
Identifier Source: org_study_id
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