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Completed

NCT Number: NCT01520792

Paracetamol and Pharmacogenetic

Recent works has emphasized that the mechanism of action of paracetamol analgesic depend on its metabolism in the body, since a breakdown product of paracetamol, the AM404 is now considered the analgesic metabolite of paracetamol suggesting as paracetamol may be a pro-drug.

Indeed, it has been shown that paracetamol may have a deleterious effect, especially in vulnerable populations (hepatic insufficiency, elderly). First results showed a very significant decrease in sulfatation and gluthatione and increased phase 1 metabolism of acetaminophen, which involves enzymes such as cytochrome P450.

Multifactorial causes, combining nutrition (depletion of sulfur amino acids), increased detoxification of toxic metabolites of paracetamol, stress or trauma are discussed to explain the results.

Clinical studies showed a great variability of pain assessment by patients and variability in the metabolic response of paracetamol. Genetic factors probably play a role remains largely unknown.

The review of the literature on genetic polymorphism shows the involvement of a number of enzymes that are well known, predominantly on the metabolism of acetaminophen liver, but without connection with its analgesic effect. This is a critical missing link in the understanding of the analgesic effect of paracetamol.

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

Randomized, single-center, placebo-controlled, double-blind, cross-over in 100 healthy volunteers meeting the inclusion criteria and receiving 2g of paracetamol orally or placebo on two study periods separated by one week.

The evaluation criterion is the difference in areas under the curve of pain thresholds to thermal and mechanical stimulations test

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers
  • Males
  • Aged between 18 and 30 years

Exclusion criteria

  • Subject without cons-indications of paracetamol

Treatment and study plan

Paracetamol (drug)

Drug

Randomized, single-center, placebo-controlled, double-blind, cross-over in 100 healthy volunteers meeting the inclusion criteria and receiving 2g of paracetamol orally or placebo on two study periods separated by one week.

Primary outcomes

  1. Correlation between Pharmacogenetic profile and pain threshold

    Time frame: until 14 days before the administration

Secondary outcomes

  1. Measures of thermal and mechanical pain thresholds

    Time frame: until 1 hour before the administration

  2. Determination of blood concentration of gluthatione

    Time frame: until 1 hour before administration

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Paracétamol and Pharmacogenetic in Healthy Volunteers

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2012
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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