Evidence map›Paper›PMID 10714612›Full record

Trial reportPharmaceutical research2000

Population pharmacokinetics of fast release oral diclofenac in healthy volunteers: relation to pharmacodynamics in an experimental pain model.

J Lötsch, B Kettenmann, B Renner, D Drover, K Brune, G Geisslinger, G Kobal

Abstract readClinical TrialControlled Clinical Trial
PubMed Publisher
In one paragraph

Trial report in Pharmaceutical research, 2000. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.7field-weighted citation impact, top 29% 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, 51 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Electroencephalography and analgesics.British journal of clinical pharmacology · 2014
    Review
  5. Understanding the hysteresis loop conundrum in pharmacokinetic/pharmacodynamic relationships.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2014
    Article
  6. Article
  7. Review
  8. Article
  9. 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

7 authors at 3 institutions in 2 countries.

J LötschStanford University School of Medicine, Department of Anesthesia, California 94305-5640, USA. j.loetsch@em.uni-frankfurt.de
B Kettenmann
B Renner
D Drover
K Brune
G Geisslinger
G Kobal
Friedrich-Alexander-Universität Erlangen-Nürnberg · DEStanford University · USGoethe University Frankfurt · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePopulation pharmacokinetics of a fast release diclofenac were assessed with special focus on pharmacodynamic implications.

methodsIn a double blind four-way crossover study, 20 healthy volunteers received orally 50 and 100 mg diclofenac-Na effervescent ("fast-release NSAID"), 50 mg diclofenac tablets ("control"), or placebo. Population pharmacokinetics of the fast release diclofenac were assessed using a nonlinear mixed effects modeling approach (NON-MEM). Analgesic effects were investigated by means of an experimental pain model based on both pain-ratings and cortical evoked potentials after specific stimulation of nasal nociceptors with short pulses of gaseous CO2.

resultsPharmacokinetics of fast release diclofenac were best described by a two-compartment population model, with an estimated terminal half-life of 1.2 hours. Pharmacokinetics of diclofenac tablets were highly variable and a population pharmacokinetic model could not be obtained. As an indication of an early onset of analgesic effects, 100 mg fast release diclofenac but not the tablets significantly reduced the amplitudes of pain-related evoked potentials at 30 min after administration.

conclusionsEarlier drug absorption and lower pharmacokinetic variability of the fast-release formulation are likely to be preserved in a population.

Indexed as

Administration, OralAdolescentAdultAnti-Inflammatory Agents, Non-SteroidalCross-Over StudiesDiclofenacDouble-Blind MethodFemaleHumansMaleMiddle AgedPainAnti-Inflammatory Agents, Non-SteroidalDiclofenac

Identifiers

PMID10714612
OpenAlexW285437985

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.