Clinical trial NCT02132247: Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Athletic Injuries
Keywords: Minor athletic injuries
Pain
Diclofenac
Topical
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2014-05-07
Enrollment: 104
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Dermatologic Assessment at the Patch Application Site
timeFrame: Up to 2 weeks, depending upon pain resolution
Secondary outcomes:
measure: Investigator Assessment of the Global Response to Therapy on a 5-point Scale
timeFrame: Up to 2 weeks, depending upon pain resolution
measure: Patient Assessment of Pain on a 6-point Scale
timeFrame: Up to 2 weeks, depending upon pain resolution
measure: Plasma Concentration of Diclofenac
timeFrame: Day 2 and either Day 4, 7 or 14, depending upon pain resolution
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Saint Petersburg
country: United States
facility: SCORE Physician Alliance
state: Florida
city: Marietta
country: United States
facility: Pediatrics and Adolescent Medicine P.A.
state: Georgia
city: Arlington
country: United States
facility: Arlington Family Research Center Inc.
state: Texas
city: Orem
country: United States
facility: Utah Valley Pediatrics
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc./Foothill Family Clininc
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc./FirstMed East
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc./Foothill Family Clinic South
state: Utah
city: West Point
country: United States
facility: Legacy Point Family Medicine
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville
state: Virginia
Study officials:
affiliation: IBSA Institut Biochimique SA
name: Clarence Jones, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Jones CA, Hoehler FK, Frangione V, Ledesma G, Wisman PP Jr, Jones C. Safety and Efficacy of the FLECTOR (Diclofenac Epolamine) Topical System in Children with Minor Soft Tissue Injuries: A Phase IV Non-randomized Clinical Trial. Clin Drug Investig. 2022 Jan;42(1):43-51. doi: 10.1007/s40261-021-01101-x. Epub 2021 Nov 26.