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

Athletic Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132247
• Other study ID #: 08US/Fp03
• Status: Completed
• Phase: Phase 4
• Start date: May 2014
• Est. completion date: May 2017

Study information

• Verified date: April 2018
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Athletic Injuries
• Soft Tissue Injuries
• Wounds and Injuries

Intervention

Drug:
• Diclofenac hydroxyethylpyrrolidine

Locations

Country	Name	City	State
United States	Arlington Family Research Center Inc.	Arlington	Texas
United States	Pediatric Research of Charlottesville	Charlottesville	Virginia
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Pediatrics and Adolescent Medicine P.A.	Marietta	Georgia
United States	Utah Valley Pediatrics	Orem	Utah
United States	SCORE Physician Alliance	Saint Petersburg	Florida
United States	J. Lewis Research Inc./FirstMed East	Salt Lake City	Utah
United States	J. Lewis Research Inc./Foothill Family Clinic South	Salt Lake City	Utah
United States	J. Lewis Research Inc./Foothill Family Clininc	Salt Lake City	Utah
United States	Legacy Point Family Medicine	West Point	Utah

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Plasma Concentration of Diclofenac		Day 2 and either Day 4, 7 or 14, depending upon pain resolution