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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • 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

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
Intervention / Treatment
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

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

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

IBSA Institut Biochimique SA

Investigators

  • 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)

May 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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