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Ankle SprainsPhase 3NCT01198834

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

A Phase 3 study testing MRX-7EAT, Lidocaine and Etodolac in people with Ankle Sprains, run by MEDRx USA, Inc. at 33 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 14 years and older
Conditions the study is for
Ankle Sprains
What is being tested?
MRX-7EAT, Lidocaine and Etodolac
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
33 sitesUnited States
Study dates
Sep 2010to Jun 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • 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 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).
  • 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.
Show all 22Show fewer
  • 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.
  • Subject has a history of drug or alcohol abuse within the past two years preceding the screening visit.
  • 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.
  • Subject has scheduled elective surgery or other invasive procedures during the period of study participation.
  • Subject is on workman's compensation or has pending legal hearings associated with any injury.
  • Subject refuses to provide informed consent or is unwilling or unable to follow study procedures.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

United States33 sites

  • Study site

    Aurora, Colorado, 80014

  • Study site

    Avon, Indiana, 46123

  • Study site

    Boise, Idaho, 83702

  • Study site

    Charlotte, North Carolina, 28207

  • Study site

    Chico, California, 95929

  • Study site

    Cincinnati, Ohio, 45246

  • Study site

    Colorado Springs, Colorado, 80907

  • Study site

    Danville, Virginia, 24541

  • Study site

    Daytona Beach, Florida, 32114

  • Study site

    Denver, Colorado, 80239

  • Study site

    Dubuque, Iowa, 52001

  • Study site

    Erlanger, Kentucky, 41018

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Fishers, Indiana, 46038

  • Study site

    Fort Lauderdale, Florida, 33334

  • Study site

    Franklin, Indiana, 46131

  • Study site

    Georgetown, Texas, 78626

  • Study site

    Greenfield, Indiana, 46140

  • Study site

    Gulf Breeze, Florida, 32561

  • Study site

    Henderson, Nevada, 89502

  • Study site

    Lubbock, Texas, 79410

  • Study site

    Muncie, Indiana, 47304

  • Study site

    North Little Rock, Arkansas, 72114

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Orlando, Florida, 32804

  • Study site

    Palm Springs, California, 92262

  • Study site

    Phoenix, Arizona, 85050

  • Study site

    Riverton, Utah, 84065

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92120

  • Study site

    Temple, Texas, 76502

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    Wichita, Kansas, 67206

Other trials in United States

About this study

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

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
Being tested
MRX-7EAT, Placebo, Lidocaine, Etodolac
Keywords
ankle sprains
Medical subject headings
Ankle Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRX-7EATDrug

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

  • PlaceboDrug

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

  • LidocaineDrug

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

  • EtodolacDrug

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

Study groups in NCT01198834
Study groupRoleWhat they receive
Placebo PatchPlacebo comparatorTreatment with Placebo Patch
Receives: Drug: Placebo
MRX-7EAT PatchExperimentalTreatment with MRX-7EAT Patch
Receives: Drug: MRX-7EAT
Lidocaine PatchExperimentalTreatment with Lidocaine Patch
Receives: Drug: Lidocaine
Etodolac PatchExperimentalTreatment with Etodolac Patch
Receives: Drug: Etodolac

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Days 2 to 7

Secondary outcomes (7)

  1. Current Pain Intensity during Point and Flex

    Measured: Days 1 through 7

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

    Measured: Each Clinical Visit

  3. Impact on Physical Function

    Measured: Days 1 to 7

  4. Total Number of Patches Used

    Measured: Days 1 to 7

  5. Time to Pain Resolution

    Measured: Days 1 to 7

  6. Assessment of Patch Adherence

    Measured: Clinical Visit 2

  7. Subject's Treatment Satisfaction

    Measured: Clinical Visit 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01198834
Sponsor's protocol ID
MRX-7EAT-1005
Status last verified
Jan 2018
First submitted
9 Sep 2010
Last updated
17 Jan 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MRX-7EAT, Lidocaine and Etodolac in people with Ankle Sprains, run by MEDRx USA, Inc. at 33 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). (time frame: Days 2 to 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01198834.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.

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