Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Paracetamol and Pharmacogenetic

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand Identifier:
First received: August 30, 2011
Last updated: May 13, 2013
Last verified: May 2013

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.

Condition Intervention Phase
Drug: Paracetamol (drug)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Paracétamol and Pharmacogenetic in Healthy Volunteers

Resource links provided by NLM:

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Correlation between Pharmacogenetic profile and pain threshold [ Time Frame: until 14 days before the administration ]

Secondary Outcome Measures:
  • Measures of thermal and mechanical pain thresholds [ Time Frame: until 1 hour before the administration ]
  • Determination of blood concentration of gluthatione [ Time Frame: until 1 hour before administration ]

Enrollment: 100
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paracetamol Drug: Paracetamol (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.

Detailed Description:

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


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Subject without cons-indications of paracetamol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01520792

CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand Identifier: NCT01520792     History of Changes
Other Study ID Numbers: CHU-0101
Study First Received: August 30, 2011
Last Updated: May 13, 2013

Keywords provided by University Hospital, Clermont-Ferrand:
pharmacogenetic of paracetamol
Pain threshold

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics processed this record on May 25, 2017