Evidence map›Paper›PMID 34826122›Full record

Trial reportClinical drug investigation2022

Safety and Efficacy of the FLECTOR (Diclofenac Epolamine) Topical System in Children with Minor Soft Tissue Injuries: A Phase IV Non-randomized Clinical Trial.

Christopher A Jones, Fred K Hoehler, Valeria Frangione, Gilbert Ledesma, Paul P Wisman, Clarence Jones

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical drug investigation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02132247 (An Open-label, Prospective, Uncontrolled Study of the Safety and Local Tolerability of the Diclofenac Epolamine Patch), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02132247 phase4completednot on this map

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

TypeinterventionalSponsorIBSA Institut Biochimique SARan2014 to 2017Enrolled104ConditionsAthletic InjuriesArmsDiclofenac hydroxyethylpyrrolidine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Strategies for Managing Pediatric Fracture Pain: Assessment, Pharmacological, and Non-Pharmacological Interventions.Medical science monitor : international medical journal of experimental and clinical research · 2024
    Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

Christopher A JonesIBSA Pharma Inc, Washington, DC, USA.
Fred K HoehlerData Management Center, Orange, CA, USA.
Valeria FrangioneIBSA Institut Biochimique SA, Via del Piano, 29, Pambio-Noranco, 6915, Lugano, Switzerland. Valeria.Frangione@ibsa.ch.
Gilbert LedesmaArlington Family Research Center, Inc., Arlington, TX, USA.
Paul P WismanPediatric Research of Charlottesville, LLC, Charlottesville, VA, USA.
Clarence JonesIBSA Pharma Inc, Washington, DC, USA.
Essa Pharma (United States) · USArlington Center for Dermatology · USCharlottesville Medical Research · USIBSA Institut Biochimique (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveA topical formulation of diclofenac (FLECTOR diclofenac epolamine topical system (FDETS)) is approved in adults for the treatment of acute pain due to minor strains, sprains, and contusions; however, its safety and efficacy have not been investigated in a pediatric population. This study assessed the safety and efficacy of the FLECTOR (diclofenac epolamine) topical system in children.

methodsThis was an open-label, single-arm, phase IV study at ten USA-based family medicine or pediatric practices in children aged 6-16 years with a clinically significant minor soft tissue injury sustained within the preceding 96 h and at least moderate spontaneous pain on the Wong-Baker FACES

results104 patients were enrolled; 52 were 6-11 years old, and 52 were 12-16 years old (mean age 11.6 years). The maximum tolerability score experienced by any patient was 1 (faint redness). Fourteen adverse events (none serious) in nine patients (8.7%) were considered possibly treatment-related. Reduction in pain during the study was somewhat greater for patients aged 6-11 versus 12-16 years (p < 0.011). The diclofenac plasma concentration tended to be higher in the younger age group compared with older patients: 1.83 versus 1.46 ng/mL at the first assessment and 2.49 versus 1.11 ng/mL at the last assessment (p = 0.002).

conclusionThe FLECTOR topical system safely and effectively provided pain relief for minor soft tissue injuries in the pediatric population, with minimal systemic nonsteroidal anti-inflammatory drug exposure and low potential risk of local or systemic adverse events. CLINICAL

trial registrationClinicalTrials.gov identifier NCT02132247.

Indexed as

Acute PainSoft Tissue InjuriesAdministration, TopicalAdolescentAnti-Inflammatory Agents, Non-SteroidalChildDiclofenacHumansPyrrolidinesAnti-Inflammatory Agents, Non-SteroidalDiclofenacdiclofenac hydroxyethylpyrrolidineepolaminePyrrolidines

Identifiers

PMID34826122
PMCPMC8755675
OpenAlexW3217029204

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.