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

NCT ID: NCT02132247

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-05-31

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.

Conditions

Athletic Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Diclofenac hydroxyethylpyrrolidine

Intervention Type: DRUG

Interventions

Diclofenac hydroxyethylpyrrolidine

Intervention Type: DRUG

Other Intervention Names

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IBSA Institut Biochimique SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clarence Jones, Ph.D.

Role: STUDY_DIRECTOR

IBSA Institut Biochimique SA

Locations

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

SCORE Physician Alliance

St. Petersburg, Florida, United States

Pediatrics and Adolescent Medicine P.A.

Marietta, Georgia, United States

Arlington Family Research Center Inc.

Arlington, Texas, United States

Utah Valley Pediatrics

Orem, Utah, United States

J. Lewis Research Inc./Foothill Family Clininc

Salt Lake City, Utah, 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

Legacy Point Family Medicine

West Point, Utah, United States

Pediatric Research of Charlottesville

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34826122 (View on PubMed)

Other Identifiers

08US/Fp03

Identifier Type: -

Identifier Source: org_study_id