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

NCT01198834 | Completed Phase 3

• 1 other identifier: MRX-7EAT-1005
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 33

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

Conditions

Ankle Sprains

Keywords

ankle sprains

Outcome Measures

Primary Outcomes (1)

• 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).

  Days 2 to 7

Secondary Outcomes (7)

• Current Pain Intensity during Point and Flex

  Days 1 through 7

• Current Pain Intensity at Rest, Passive Stretch and Pain Intensity While Standing On a Single Foot

  Each Clinical Visit

• Impact on Physical Function

  Days 1 to 7

• Total Number of Patches Used

  Days 1 to 7

• Time to Pain Resolution

  Days 1 to 7

Study Arms (4)

Placebo Patch

PLACEBO COMPARATOR

Treatment with Placebo Patch

Drug: Placebo

MRX-7EAT Patch

EXPERIMENTAL

Treatment with MRX-7EAT Patch

Drug: MRX-7EAT

Lidocaine Patch

EXPERIMENTAL

Treatment with Lidocaine Patch

Drug: Lidocaine

Etodolac Patch

EXPERIMENTAL

Treatment with Etodolac Patch

Drug: Etodolac

Interventions

MRX-7EAT DRUG

Application of up to two patches at the discretion of the investigator for up to 7 days.

MRX-7EAT Patch

Placebo DRUG

Application of up to two patches at the discretion of the investigator for up to 7 days.

Placebo Patch

Lidocaine DRUG

Application of up to two patches at the discretion of the investigator for up to 7 days.

Lidocaine Patch

Etodolac DRUG

Application of up to two patches at the discretion of the investigator for up to 7 days.

Etodolac Patch

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed an informed consent form.
• 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 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.
• 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.
• 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").
• Subject is willing and able to comply with the protocol.

You may not qualify if:

• 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).
• 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.
• 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.
• 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.
• 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.
• 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®).
• 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.
• Subject has used TNF alpha blockers or Class 1 anti-arrhythmic drugs within the 60 days preceding the screening visit.
• 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 as determined by the study investigator.
• 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.
• Subject has any 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. Skin lesions include open wounds, rash, papules and vesicles; abrasions, lacerations or any break in skin at the intended site of patch application.
• 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 (Flector® Patch or Voltaren® Gel) defined as repeated attempts within the three months preceding the screening visit.

Sponsors & Collaborators

• MEDRx USA, Inc.: lead

Study Sites (33)

Unknown Facility

Phoenix, Arizona, 85050, United States

Location

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North Little Rock, Arkansas, 72114, United States

Location

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Chico, California, 95929, United States

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Palm Springs, California, 92262, United States

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San Diego, California, 92120, United States

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Aurora, Colorado, 80014, United States

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Colorado Springs, Colorado, 80907, United States

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Denver, Colorado, 80239, United States

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Daytona Beach, Florida, 32114, United States

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Fort Lauderdale, Florida, 33334, United States

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Gulf Breeze, Florida, 32561, United States

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Orlando, Florida, 32804, United States

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West Palm Beach, Florida, 33409, United States

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Boise, Idaho, 83702, United States

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Avon, Indiana, 46123, United States

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Fishers, Indiana, 46038, United States

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Franklin, Indiana, 46131, United States

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Greenfield, Indiana, 46140, United States

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Muncie, Indiana, 47304, United States

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Dubuque, Iowa, 52001, United States

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Wichita, Kansas, 67206, United States

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Erlanger, Kentucky, 41018, United States

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Henderson, Nevada, 89502, United States

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Charlotte, North Carolina, 28207, United States

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Fargo, North Dakota, 58103, United States

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Cincinnati, Ohio, 45246, United States

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Oklahoma City, Oklahoma, 73112, United States

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Georgetown, Texas, 78626, United States

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Lubbock, Texas, 79410, United States

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San Antonio, Texas, 78229, United States

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Temple, Texas, 76502, United States

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Riverton, Utah, 84065, United States

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Unknown Facility

Danville, Virginia, 24541, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Lidocaine; Etodolac

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indoleacetic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Martine Francis

  IL Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

US (33)