Evidence map›Paper›PMID 32922524›Full record

ArticleTherapeutic advances in musculoskeletal disease2020

Penetration of topical diclofenac into synovial tissue and fluid of osteoarthritic knees: a multicenter, randomized, placebo-controlled, pharmacokinetic study.

Lothar Seefried, Mark Blyth, Rohit Maheshwari, Stephen M McDonnell, Guillaume Frappin, Martina Hagen, Nadine Maybaum, Sebastian Moreira, Hemant Pandit

Open access · goldAbstract read
In one paragraph

Article in Therapeutic advances in musculoskeletal disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 11% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
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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

9 authors at 5 institutions in 2 countries.

Lothar SeefriedClinical Trial Unit, Orthopaedic Department, University Würzburg, Brettreichtstr 11, Würzburg, Bavaria 97074, Germany.ORCID https://orcid.org/0000-0003-1154-3388
Mark BlythDepartment of Orthopaedic Surgery, Glasgow Royal Infirmary, Glasgow, UK.
Rohit MaheshwariDepartment of Orthopaedic Surgery, Golden Jubilee National Hospital, Clydebank, UK.
Stephen M McDonnellAddenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Guillaume FrappinGlaxoSmithKline Consumer Healthcare S.A., Nyon, Switzerland.
Martina HagenGlaxoSmithKline Consumer Healthcare S.A., Nyon, Switzerland.
Nadine MaybaumGSK Consumer Healthcare, Warren, NJ, USA.
Sebastian MoreiraGSK Consumer Healthcare, Warren, NJ, USA.
Hemant PanditLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Leeds, UK.
GlaxoSmithKline (Switzerland) · CHCambridge University Hospitals NHS Foundation Trust · GBGlasgow Royal Infirmary · GBGolden Jubilee National Hospital · GBUniversity of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTopical diclofenac, a nonsteroidal anti-inflammatory drug, has proven efficacy and safety in the management of osteoarthritis pain. We investigated penetration of topical diclofenac into knee synovial tissue and fluid (primary objective) and evaluated relative exposure in the knee

methodsIn this phase I, double-blind, multicenter study, patients scheduled for arthroplasty for end-stage knee osteoarthritis were randomly assigned 2:1 to 4 g diclofenac diethylamine 2.32% w/w gel (92.8 mg diclofenac diethylamine, equivalent to 74.4 mg diclofenac, per application) or placebo gel, applied to the affected knee by a trained nurse/designee every 12 h for 7 days before surgery. Diclofenac concentrations were measured in synovial tissue, synovial fluid and plasma from samples obtained during surgery ⩾12 h after last application. Treatment-emergent adverse events (TEAEs) were evaluated.

resultsEvaluable synovial tissue or fluid samples were obtained from 45 (diclofenac

conclusionsTopical diclofenac diethylamine 2.32% w/w gel penetrated into the osteoarthritic knee after repeated application and remained detectable in synovial tissue and fluid at the end of the final 12 h dosing cycle.

Indexed as

diclofenacnonsteroidal anti-inflammatory agentsosteoarthritispharmacokinetics; tissue distribution

Identifiers

PMID32922524
PMCPMC7457412
OpenAlexW3081732699

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Registered trials

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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.