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

NCT02132247 | Completed Phase 4 Results

• 1 other identifier: 08US/Fp03
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 10

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

Keywords

Minor athletic injuries; Pain; Diclofenac; Topical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Investigator Assessment of the Global Response to Therapy on a 5-point Scale

  Up to 2 weeks, depending upon pain resolution

• Patient Assessment of Pain on a 6-point Scale

  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

Study Arms (1)

Flector Patch

EXPERIMENTAL

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

Interventions

Diclofenac hydroxyethylpyrrolidine DRUG

Also known as: Flector Patch

Flector Patch

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (10)

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

SCORE Physician Alliance

St. Petersburg, Florida, 33710, United States

Location

Pediatrics and Adolescent Medicine P.A.

Marietta, Georgia, 30062, United States

Location

Arlington Family Research Center Inc.

Arlington, Texas, 76012, United States

Location

Utah Valley Pediatrics

Orem, Utah, 84057, United States

Location

J. Lewis Research Inc./Foothill Family Clininc

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research Inc./FirstMed East

Salt Lake City, Utah, 84121, United States

Location

J. Lewis Research Inc./Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Legacy Point Family Medicine

West Point, Utah, 84015, United States

Location

Pediatric Research of Charlottesville

Charlottesville, Virginia, 22902, United States

Location

Related Publications (1)

• 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.

  PMID: 34826122 DERIVED

MeSH Terms

Conditions

Athletic Injuries; Pain

Interventions

diclofenac hydroxyethylpyrrolidine

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christopher Jones, Ph.D.
• Organization: IBSA Pharma Inc.

chris.jones@ibsapharma.com

(202) 753-6475

Study Officials

• Clarence Jones, Ph.D.

  IBSA Institut Biochimique SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 7, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: May 1, 2017
• Last Updated: May 11, 2018
• Results First Posted: May 11, 2018

Record last verified: 2018-04

Locations

US (10)