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MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains

This study has been completed.
Sponsor:
Collaborator:
MEDRx Co., Ltd.
Information provided by (Responsible Party):
IL Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01198834
First received: September 9, 2010
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Ankle Sprains
Drug: MRX-7EAT
Drug: Placebo
Drug: Lidocaine
Drug: Etodolac
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by IL Pharma Inc.:

Primary Outcome Measures:
  • 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). [ Time Frame: Days 2 to 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Current Pain Intensity during Point and Flex [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: No ]
  • Current Pain Intensity at Rest, Passive Stretch and Pain Intensity While Standing On a Single Foot [ Time Frame: Each Clinical Visit ] [ Designated as safety issue: No ]
  • Impact on Physical Function [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: No ]
  • Total Number of Patches Used [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: No ]
  • Time to Pain Resolution [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: No ]
  • Assessment of Patch Adherence [ Time Frame: Clinical Visit 2 ] [ Designated as safety issue: No ]
  • Subject's Treatment Satisfaction [ Time Frame: Clinical Visit 3 ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Patch
Treatment with Placebo Patch
Drug: Placebo
Application of up to two patches at the discretion of the investigator for up to 7 days.
Experimental: MRX-7EAT Patch
Treatment with MRX-7EAT Patch
Drug: MRX-7EAT
Application of up to two patches at the discretion of the investigator for up to 7 days.
Experimental: Lidocaine Patch
Treatment with Lidocaine Patch
Drug: Lidocaine
Application of up to two patches at the discretion of the investigator for up to 7 days.
Experimental: Etodolac Patch
Treatment with Etodolac Patch
Drug: Etodolac
Application of up to two patches at the discretion of the investigator for up to 7 days.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198834

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85050
United States, Arkansas
North Little Rock, Arkansas, United States, 72114
United States, California
Chico, California, United States, 95929
Palm Springs, California, United States, 92262
San Diego, California, United States, 92120
United States, Colorado
Aurora, Colorado, United States, 80014
Colorado Springs, Colorado, United States, 80907
Denver, Colorado, United States, 80239
United States, Florida
Daytona Beach, Florida, United States, 32114
Ft. Lauderdale, Florida, United States, 33334
Gulf Breeze, Florida, United States, 32561
Orlando, Florida, United States, 32804
West Palm Beach, Florida, United States, 33409
United States, Idaho
Boise, Idaho, United States, 83702
United States, Indiana
Avon, Indiana, United States, 46123
Fishers, Indiana, United States, 46038
Franklin, Indiana, United States, 46131
Greenfield, Indiana, United States, 46140
Muncie, Indiana, United States, 47304
United States, Iowa
Dubuque, Iowa, United States, 52001
United States, Kansas
Wichita, Kansas, United States, 67206
United States, Kentucky
Erlanger, Kentucky, United States, 41018
United States, Nevada
Henderson, Nevada, United States, 89502
United States, North Carolina
Charlotte, North Carolina, United States, 28207
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Cincinnati, Ohio, United States, 45246
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
Georgetown, Texas, United States, 78626
Lubbock, Texas, United States, 79410
San Antonio, Texas, United States, 78229
Temple, Texas, United States, 76502
United States, Utah
Riverton, Utah, United States, 84065
United States, Virginia
Danville, Virginia, United States, 24541
Sponsors and Collaborators
IL Pharma Inc.
MEDRx Co., Ltd.
Investigators
Study Director: Martine Francis IL Pharma
  More Information

No publications provided

Responsible Party: IL Pharma Inc.
ClinicalTrials.gov Identifier: NCT01198834     History of Changes
Other Study ID Numbers: MRX-7EAT-1005
Study First Received: September 9, 2010
Last Updated: June 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by IL Pharma Inc.:
ankle sprains

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries
Etodolac
Lidocaine
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 25, 2014