Evidence map›Paper›PMID 17363401›Full record

Trial reportAnnals of the rheumatic diseases2007

Efficacy and safety of epicutaneous ketoprofen in Transfersome (IDEA-033) versus oral celecoxib and placebo in osteoarthritis of the knee: multicentre randomised controlled trial.

Matthias Rother, Bernard J Lavins, Werner Kneer, Klaus Lehnhardt, Egbert J Seidel, Stefan Mazgareanu

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00317733 (A Double-Blind, Placebo-Controlled Evaluation of Safety and Efficacy of Epicutaneously Applied IDEA-033), which is not on this map. Cited by 39 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 10 pooled it
5.1field-weighted citation impact, top 5% 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.

NCT00317733 phase2completednot on this map

A Double-Blind, Placebo-Controlled Evaluation of Safety and Efficacy of Epicutaneously Applied IDEA-033 (Ketoprofen in Transfersome) in Comparison to Oral Celecoxib for the Treatment of Pain Associated With Osteoarthritis of the Knee

TypeinterventionalSponsorIDEA AGEnrolled360ConditionsOsteoarthritis, KneeArmsKetoprofen in Transfersome
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 10 syntheses or guidelines pooled it, 113 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Celecoxib for osteoarthritis.The Cochrane database of systematic reviews · 2017
    Pooled it
  8. Topical NSAIDs for chronic musculoskeletal pain in adults.The Cochrane database of systematic reviews · 2016
    Pooled it
  9. Topical NSAIDs for chronic musculoskeletal pain in adults.The Cochrane database of systematic reviews · 2012
    Pooled it
  10. Pooled it
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Article
  16. Review
  17. Review
  18. Review
  19. Review
  20. Pain management in hidradenitis suppurativa and a proposed treatment algorithm.Journal of the American Academy of Dermatology · 2021
    Review
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.

Matthias RotherIDEA AG, Frankfurter Ring 193a, 80807 Muenchen, Germany. rother@idea-ag.de
Bernard J Lavins
Werner Kneer
Klaus Lehnhardt
Egbert J Seidel
Stefan Mazgareanu
Individual Development and Adaptive Education · DEIDEA (Germany) · DEMcNeil Center for Early American Studies · USSentient Science (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare epicutaneous ketoprofen in Transfersome (ultra-deformable vesicles, IDEA-033) versus oral celecoxib and placebo for relief of signs and symptoms in knee osteoarthritis.

methodsThis was a multicentre, randomised, double-blind, controlled trial; 397 patients with knee osteoarthritis participated and 324 completed the trial. They were randomly assigned 110 mg epicutaneous ketoprofen in 4.8 g Transfersome plus oral placebo (n = 138), 100 mg oral celecoxib plus placebo gel (n = 132), or both placebo formulations (n = 127) twice daily for 6 weeks. Primary efficacy outcome measures were the changes from baseline to end of the study on the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index pain subscale, physical function subscale and patient global assessment (PGA) of response.

resultsThe mean WOMAC pain subscale scores in the intent to treat population were reduced by 18.2 (95% confidence interval -22.1 to -14.3), 20.3 (-24.3 to -16.2) and 9.9 (-13.9 to -5.8) in the IDEA-033, celecoxib and placebo groups, respectively, and the physical function subscale score by 14.6 (-18.1 to -11.0), 16.6 (-20.2 to -13.0) and 10.2 (-13.8 to -6.6), respectively. The mean PGA of response scores were 1.8 (1.6 to 2.1), 1.7 (1.5 to 1.9) and 1.3 (1.1 to 1.5), respectively. The differences in change between IDEA-033 and placebo were statistically significant for pain subscale (p<0.01) and PGA of response (p<0.01). Gastrointestinal adverse events for IDEA-033 were similar to placebo.

conclusionIDEA-033 is superior to placebo and comparable with celecoxib in relieving pain associated with an acute flare of knee osteoarthritis.

Indexed as

Administration, CutaneousAdministration, OralAgedAnti-Inflammatory Agents, Non-SteroidalCelecoxibDisability EvaluationDouble-Blind MethodDrug CarriersFemaleHumansKetoprofenLeast-Squares AnalysisMaleMiddle AgedOsteoarthritis, KneePain MeasurementAnti-Inflammatory Agents, Non-SteroidalCelecoxibDrug CarriersKetoprofenPyrazolesSulfonamides

Identifiers

PMID17363401
PMCPMC1955127
OpenAlexW2120551915

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.