Evidence map›Paper›PMID 31161580›Full record

Trial reportDrugs & aging2019

Population Pharmacokinetic/Pharmacodynamic Modeling of O-Desmethyltramadol in Young and Elderly Healthy Volunteers.

Sybil Skinner Robertson, Mohamad Samer Mouksassi, France Varin

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Drugs & aging, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02329561 (Comparative, Randomized, Double-Blind, Single-Dose, 2-way Crossover Study to Evaluate the Pharmacokinetics and Analgesic Effect of Labopharm Tramadol Contramid® OAD 200 mg Tablets or Placebo in Healthy Young and Elderly Adult Volunteers), 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
0.5field-weighted citation impact, top 34% 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.

NCT02329561 phase1completednot on this map

Comparative, Randomized, Double-Blind, Single-Dose, 2-way Crossover Study to Evaluate the Pharmacokinetics and Analgesic Effect of Labopharm Tramadol Contramid® OAD 200 mg Tablets or Placebo in Healthy Young and Elderly Adult Volunteers

TypeinterventionalSponsorUniversité de MontréalRan2007 to 2007Enrolled35ConditionsAging, PainArmsTramadol extended release 200 mg, CP/T, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Role of Pharmacogenetics on Tramadol Pharmacokinetics: A Population Pharmacokinetic Model.European journal of drug metabolism and pharmacokinetics · 2026
    Article
  2. Review
  3. Article
  4. Population Pharmacokinetic Model for Tramadol and O-desmethyltramadol in Older Patients.European journal of drug metabolism and pharmacokinetics · 2022
    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

3 authors at 2 institutions in 1 country.

Sybil Skinner RobertsonFaculté de Pharmacie, Université de Montréal, Succursale Centre-Ville, C.P. 6128, Montréal, Québec, H3C 3J7, Canada.
Mohamad Samer MouksassiFaculté de Pharmacie, Université de Montréal, Succursale Centre-Ville, C.P. 6128, Montréal, Québec, H3C 3J7, Canada.
France VarinFaculté de Pharmacie, Université de Montréal, Succursale Centre-Ville, C.P. 6128, Montréal, Québec, H3C 3J7, Canada. France.Varin@umontreal.ca.ORCID 0000-0001-6362-4580
Université de Montréal · CAUniversité du Québec · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAge-related changes in the concentration-effect relationship of (+)-O-desmethyl-tramadol [(+)-ODM], tramadol's active metabolite, are not documented in the elderly.

objectiveThe objective of this study was to characterize, in elderly and young subjects, the (+)-ODM pharmacokinetic and pharmacodynamic relationship to examine the effect of age after single-dose administration of tramadol 200 mg extended-release tablets.

methodsA population analysis of a double-blind, randomized, placebo-controlled, two-period cross-over study including 13 elderly (aged ≥75 years) subjects with mild renal insufficiency and 16 young (aged 18-40 years) subjects was conducted. For 48 h post-dose, blood samples were collected and pain tolerance thresholds measured using an electrically stimulated pain model. A pharmacokinetic/pharmacodynamic model incorporating a one-compartment pharmacokinetic model for (+)-ODM parameterized with first-order formation rate, clearance (CL/f

resultsMaximum plasma concentrations of (+)-ODM occurred later and plasma concentrations declined more slowly in the elderly than in young subjects. In the elderly, V/f

conclusionsThis exploratory analysis suggests that age-related differences exist in the distribution and elimination of (+)-ODM, including a 76% larger distribution outside the central compartment and 16% slower clearance of (+)-ODM. These pharmacokinetic changes are associated with a 15% higher maximum possible treatment-related effect and carry the potential for greater efficacy but also the potential for increased side effects at the same dose in elderly subjects. Clinicaltrials.gov identifier: NCT02329561.

Indexed as

Models, BiologicalAdolescentAdultAgedAgingAnalgesics, OpioidCross-Over StudiesDouble-Blind MethodElectric StimulationFemaleHealthy VolunteersHumansMaleMiddle AgedPainTramadolAnalgesics, OpioidO-demethyltramadolTramadol

Identifiers

PMID31161580
OpenAlexW2948894715

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.