MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains
NCT ID: NCT01198834
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
600 participants
INTERVENTIONAL
2010-09-30
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
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Placebo Patch
Treatment with Placebo Patch
Placebo
Application of up to two patches at the discretion of the investigator for up to 7 days.
MRX-7EAT Patch
Treatment with MRX-7EAT Patch
MRX-7EAT
Application of up to two patches at the discretion of the investigator for up to 7 days.
Lidocaine Patch
Treatment with Lidocaine Patch
Lidocaine
Application of up to two patches at the discretion of the investigator for up to 7 days.
Etodolac Patch
Treatment with Etodolac Patch
Etodolac
Application of up to two patches at the discretion of the investigator for up to 7 days.
Interventions
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MRX-7EAT
Application of up to two patches at the discretion of the investigator for up to 7 days.
Placebo
Application of up to two patches at the discretion of the investigator for up to 7 days.
Lidocaine
Application of up to two patches at the discretion of the investigator for up to 7 days.
Etodolac
Application of up to two patches at the discretion of the investigator for up to 7 days.
Eligibility Criteria
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Inclusion Criteria
1. Subject has signed an informed consent form.
2. Subject is 14 years of age or older (with assent according to state law).
3. Females of child bearing potential must have a negative pregnancy test and be using an adequate method of birth control. Adequate is defined as either hormonal or partner vasectomy for at least three months, or , condoms, IUD, abstinence or other prescribed birth control. Females may be considered non-childbearing if post-menopausal at least 1 year or surgically sterile.
4. Subject has a diagnosis of uncomplicated acute soft tissue inversion injury of the ankle, Grade II classification (as defined by the American Academy of Orthopaedic Surgeons (AAOS), "partial tearing of the ligament") that has occurred ≥ 6 hours to ≤ 48 hours before study entry.
5. Subject has a Current Pain Intensity during point and flex with the ankle unwrapped rated prior to study entry as ≥ 5 but ≤ 8 on an NPRS (11 point; range 0 to 10; anchors to be "none" and "severe").
6. Subject is willing and able to comply with the protocol.
Exclusion Criteria
1. Females of child bearing potential that are not using an adequate method of birth control or are breastfeeding (adequate defined as either hormonal or partner vasectomy for at least three months, or other prescribed birth control, condoms, IUD, abstinence or other prescribed birth control).
2. Subject has a Grade I ("slight stretching and some damage to the fibers (fibrils) of the ligament") or Grade III ("complete tear of the ligament") sprain or strain, bilateral sprain or strain, or concomitant fracture or open wound at the site of the sprain or strain, or has a serious injury, as determined by the investigator (e.g., nerve damage, joint instability, or tendon rupture); or surgical treatment is required. Diagnosis of Grade III is indicated by a positive anterior drawer test or positive talar tilt test is exclusionary (inability to perform test(s) is exclusionary when in the opinion of the investigator a Grade III sprain is suspected).
3. Subject has a history of a previous injury to the same area within two months prior to current injury or previous surgery in the same area.
4. Subject has used non-pharmacologic treatments for the injury within 2 hours prior to the baseline visit (e.g. ice or acupuncture) that may interfere with pain assessments. Subjects on any therapeutic exercise regimen should continue based on the investigator's discretion. Use of iontophoresis is prohibited.
5. Subject has used oral pharmacologic treatments (NSAIDs or analgesic medications) for the injury less than three half-lives before the baseline assessments; ibuprofen is permitted prior to baseline as long as it is not within six hours of the baseline assessment aspirin (81-325 mg daily) taken prophylactically for cardiovascular reasons is permitted.
6. Subject has used any form of opioid within 24 hours of study entry or used opioids for five or more consecutive days within the 30 days preceding the screening visit.
7. Subject has received systemic corticosteroids in the 30 days preceding the screening visit (e.g., intra-articular, peritendinous, oral, or parenteral administration); topical corticosteroid use is acceptable unless applied to the target joint; and inhaled steroids are acceptable (e.g. Flonase®).
8. Subject recently initiated sleep medications, muscle relaxants, anticonvulsants or antidepressants (within the past 30 days); if using any of these, subject must be on a stable dose and regimen for 30 days prior to study enrollment.
9. Subject has used TNF alpha blockers or Class 1 anti-arrhythmic drugs within the 60 days preceding the screening visit.
10. 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.
11. Subject has a history or physical assessment finding that is not compatible with safe participation in the study as determined by the study investigator.
12. Subject has any form of inflammatory arthritis, spondyloarthropathies (sPA), fibromyalgia, or is currently undergoing treatment for chronic pain; or has a history of, or evidence for, underlying disease in the injured area, such as osteoarthritis or gout.
13. Subject has any pain or medical problem that, in the investigator's opinion, may interfere with pain measurement of the target joint.
14. Subject has active skin lesions or disease at the intended site of application of the study medication. Skin lesions include open wounds, rash, papules and vesicles; abrasions, lacerations or any break in skin at the intended site of patch application.
15. Subject has a history of allergy to etodolac, other NSAIDs, lidocaine, or adhesives (e.g. adhesive tape).
16. Subject has a history of prior failed treatment with topical NSAIDs (Flector® Patch or Voltaren® Gel) defined as repeated attempts within the three months preceding the screening visit.
17. Subject has a history of drug or alcohol abuse within the past two years preceding the screening visit.
18. Subject has received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication.
19. Subject has scheduled elective surgery or other invasive procedures during the period of study participation.
20. Subject is on workman's compensation or has pending legal hearings associated with any injury.
21. Subject refuses to provide informed consent or is unwilling or unable to follow study procedures.
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_DIRECTOR
IL Pharma
Locations
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Phoenix, Arizona, United States
North Little Rock, Arkansas, United States
Chico, 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
Boise, Idaho, 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
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-1005
Identifier Type: -
Identifier Source: org_study_id
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