Clinical trial NCT01198834: MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains
Official title: A Randomized, Multi-Center, Double-Blind, Factorial, Comparator and Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankle Sprains
Keywords: ankle sprains
Lead sponsor: MEDRx USA, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 600
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A Randomized, Multi-Center, Double-Blind, Factorial, Comparator and Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains


Eligibility criteria: Inclusion Criteria

A subject will be eligible for inclusion in this study if all of the following criteria apply:

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

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

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.

Primary outcomes:
measure: Mean of All Current Pain Intensity During Point and Flex Scores on Days 2 Through 7 on a 0-10 Numeric Pain Rating Scale (NPRS).
timeFrame: Days 2 to 7
Secondary outcomes:
measure: Current Pain Intensity during Point and Flex
timeFrame: Days 1 through 7
measure: Current Pain Intensity at Rest, Passive Stretch and Pain Intensity While Standing On a Single Foot
timeFrame: Each Clinical Visit
measure: Impact on Physical Function
timeFrame: Days 1 to 7
measure: Total Number of Patches Used
timeFrame: Days 1 to 7
measure: Time to Pain Resolution
timeFrame: Days 1 to 7
measure: Assessment of Patch Adherence
timeFrame: Clinical Visit 2
measure: Subject's Treatment Satisfaction
timeFrame: Clinical Visit 3
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: North Little Rock
country: United States
state: Arkansas
city: Chico
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Daytona Beach
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Gulf Breeze
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Avon
country: United States
state: Indiana
city: Fishers
country: United States
state: Indiana
city: Franklin
country: United States
state: Indiana
city: Greenfield
country: United States
state: Indiana
city: Muncie
country: United States
state: Indiana
city: Dubuque
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Erlanger
country: United States
state: Kentucky
city: Henderson
country: United States
state: Nevada
city: Charlotte
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Georgetown
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Riverton
country: United States
state: Utah
city: Danville
country: United States
state: Virginia
Study officials:
affiliation: IL Pharma
name: Martine Francis
role: STUDY_DIRECTOR
References: