Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries

April 9, 2018 updated by: IBSA Institut Biochimique SA

An Open-label, Prospective, Uncontrolled Study of the Safety and Local Tolerability of the Diclofenac Epolamine Patch (Flector Patch) in Pediatric Patients With Minor Soft Tissue Injuries

The primary purpose of this study is to determine whether Flector Patch is safe for use in children. The secondary purpose is to assess blood levels of diclofenac, the active ingredient in Flector Patch.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Applied Research Center of Arkansas
    • Florida
      • Saint Petersburg, Florida, United States, 33710
        • SCORE Physician Alliance
    • Georgia
      • Marietta, Georgia, United States, 30062
        • Pediatrics and Adolescent Medicine P.A.
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Family Research Center Inc.
    • Utah
      • Orem, Utah, United States, 84057
        • Utah Valley Pediatrics
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research Inc./Foothill Family Clininc
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research Inc./FirstMed East
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research Inc./Foothill Family Clinic South
      • West Point, Utah, United States, 84015
        • Legacy Point Family Medicine
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Pediatric Research of Charlottesville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 6 to 16 years, either gender
  • Informed consent: 6-9 year olds must have their parent/legally authorized representative complete a Parental Permission Form; 10-16 year olds must complete a Children's Assent Form and have their parent/legally authorized representative complete a Parental Permission Form
  • Minor soft tissue injury within 96 hours of study entry
  • Spontaneous pain of at least moderate intensity (i.e. pain of at least 3 on the 6-point Wong- Baker Faces scale for pain severity assessment by patient)
  • Injury must be considered by the Investigator to be clinically significant
  • Negative urine pregnancy test at screening for female subjects of childbearing potential (started the menstrual cycle)
  • Able to read and speak English
  • Available with their parents for the immediate two week period following study enrollment

Exclusion Criteria:

  • Major soft tissue injury (Fractures are only exclusionary if the injury is stabilized with a device, e.g. a hard cast, that cannot be removed to allow a patch to be applied to the site of injury)
  • Open skin lesion or any dermatological condition (e.g. skin infection, eczema) within the injured area
  • Injury is midline or involves the spine, digits or hands
  • Prior injury to the same site within the past 3 months
  • Three or more other prior injuries (minor or major) to the region in the past
  • Injury occurred more than 96 hours prior to study entry
  • Prior use of topical medication to involved area within 48 hours of study entry
  • Allergic disorders, including asthma or urticaria, but only if associated with exposure to aspirin or an NSAID
  • Coagulation defects
  • Prior use of over-the-counter (OTC) analgesics or short-acting non-steroidal anti-inflammatory drugs (NSAIDs [ibuprofen, ketoprofen]) within 6 hours of study entry (acetaminophen permitted up until the time of study entry)
  • Prior use of narcotic analgesics within 7 days of study entry
  • Prior use of systemic anti-inflammatory steroidal drugs within 60 days of study entry
  • Prior use of long-acting NSAIDs such as piroxicam or naproxen since injury
  • Concomitant use of drugs which may be susceptible to interactions with diclofenac, or affect safety if used concomitantly (serotonin-selective reuptake inhibitors (SSRI), lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs, steroids and diuretics)
  • Subjects suffering from psychiatric disorders (including depression)
  • Handicapped patients, but only if the handicap prevents them from either assessing their pain or safely using the patch (e.g., pervasive developmental disorders such as autism, Asperger syndrome, Rett syndrome, Heller's syndrome, severe attention deficit hyperactivity disorders (ADHD), other severe mental retardation of traumatic, congenital or other origin)
  • History of current alcohol or drug abuse dated < 1 year
  • Severe cardiac, renal or hepatic impairment
  • Severe systemic diseases (e.g. cancer, severe acute infection)
  • Any underlying disease or medication that severely compromise the patient's immune system
  • Prior history of any chronic pain disorder
  • Prior history of GI bleeds/ulcers, liver or kidney disease
  • Hypersensitivity to diclofenac or other NSAID drugs (including aspirin)
  • Females who are pregnant or breast feeding
  • Patients participating or having been involved in other clinical investigations during the three months preceding the entry of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Flector Patch
Flector Patch is a transdermal delivery system containing 180 mg of diclofenac hydroxyethylpyrrolidine. The patch will be used twice-a-day for up to two weeks, or until pain resolution, whichever comes first.
Drug: Diclofenac hydroxyethylpyrrolidine
Other Names:
  • Flector Patch

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dermatologic Assessment at the Patch Application Site
Time Frame: Up to 2 weeks, depending upon pain resolution
None - 0; Faint redness - 1; Moderate redness - 2; Intense redness - 3; Redness with edema or papules - 4; Redness with weeping vesicles, blisters or bullae - 5; Redness with extension of effect beyond margin of contact site - 6.
Up to 2 weeks, depending upon pain resolution

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Investigator Assessment of the Global Response to Therapy on a 5-point Scale
Time Frame: Up to 2 weeks, depending upon pain resolution
5-point scale: No clinical improvement in pain intensity and/or functional performance - 1; Slight clinical improvement in pain intensity and/or functional performance - 2; Moderate clinical improvement in pain intensity and/or functional performance - 3; Marked clinical improvement in pain intensity and/or functional performance - 4; Restoration of normal functional performance in the absence of any pain - 5.
Up to 2 weeks, depending upon pain resolution
Patient Assessment of Pain on a 6-point Scale
Time Frame: Up to 2 weeks, depending upon pain resolution

Wong-Baker FACES Scale 6-point scale:

No Hurt - 0; Hurts Little Bit - 1; Hurts Little More - 2; Hurts Even More - 3; Hurts Whole Lot - 4; Hurts Worst - 5.
Up to 2 weeks, depending upon pain resolution
Plasma Concentration of Diclofenac
Time Frame: Day 2 and either Day 4, 7 or 14, depending upon pain resolution
Day 2 and either Day 4, 7 or 14, depending upon pain resolution

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IBSA Institut Biochimique SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clarence Jones, Ph.D., IBSA Institut Biochimique SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 08US/Fp03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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