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Trial record 22 of 452 for:    DICLOFENAC

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02132247
Recruitment Status : Completed
First Posted : May 7, 2014
Results First Posted : May 10, 2018
Last Update Posted : May 10, 2018
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Athletic Injuries Drug: Diclofenac hydroxyethylpyrrolidine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sports Injuries

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 Name: Flector Patch

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Plasma Concentration of Diclofenac [ Time Frame: Day 2 and either Day 4, 7 or 14, depending upon pain resolution ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02132247

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

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Responsible Party: IBSA Institut Biochimique SA Identifier: NCT02132247     History of Changes
Other Study ID Numbers: 08US/Fp03
First Posted: May 7, 2014    Key Record Dates
Results First Posted: May 10, 2018
Last Update Posted: May 10, 2018
Last Verified: April 2018
Keywords provided by IBSA Institut Biochimique SA:
Minor athletic injuries
Additional relevant MeSH terms:
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Diclofenac hydroxyethylpyrrolidine
Soft Tissue Injuries
Athletic Injuries
Wounds and Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action