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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Athletic Injuries

Intervention / Treatment
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* Drug: Diclofenac hydroxyethylpyrrolidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flector Patch<br>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<br> <br> * Other names: Flector Patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatologic Assessment at the Patch Application Site | 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 | 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 | 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 |  | Day 2 and either Day 4, 7 or 14, depending upon pain resolution | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minor athletic injuries, Pain, Diclofenac, Topical