Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

CYTRAM (Cytochrome P450, Tramadol)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00952159
First received: August 3, 2009
Last updated: July 1, 2011
Last verified: July 2011

August 3, 2009
July 1, 2011
April 2010
June 2011   (final data collection date for primary outcome measure)
To phenotype CYP2D6 in post-operative patients treated by tramadol by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in comparison with genotype, and to find a threshold to determine poor metabolizers. [ Time Frame: H24 and H48 after surgery ] [ Designated as safety issue: No ]
To phenotype CYP2D6 in post-operative patients treated by tramadol by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in comparision with genotype, and to find a threeshold to determine poor metabolizers. [ Time Frame: H24 and H48 after surgery ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00952159 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
CYTRAM (Cytochrome P450, Tramadol)
Validation of a New Method to Detect CYP2D6 Poor Metabolizers by Monitoring Seric Concentrations of O-demethyl-tramadol and Tramadol to Make a Ratio in Comparison With Genotyping in Post-operative Patients Treated With Intravenous Tramadol

Many methods to detect CYP2D6 poor metabolizers have been validated. Some of them are based on phenotyping (metabolism of dextromethorphan or debrisoquine) and some others on genotyping. Up to now, CYP2D6 pharmacogenetics has been restricted to the field of research, in spite of poor metabolizer profile concerns 5 to 10 % of caucasian population. Nevertheless, the polymorphism of CYP2D6 is responsible for the metabolism of many drugs, particularly of two opioids involved in pain management: codeine and tramadol, their metabolites representing the most effective part of the drug effect. So prescribing codeine or tramadol in a patient poor metabolizer for the CYP2D6 is likely to be ineffective in pain management.

O-demethyl-tramadol, the metabolite of tramadol via CYP2D6, is important to consider because its analgesic effect is 2 to 4 times more potent than tramadol.

The investigators propose to phenotype CYP2D6 in post-operative patients treated by tramadol by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in comparison with genotype, and to find a threshold to determine poor metabolizers. As already described, genotyping CYP2D6 will use a rapid detection method of the alleles implicated in poor metabolizer status (CYP2D6*3, *4, *5 et *6) in a Caucasian population. Sampling will be executed at two times (H24 and H48 after surgery) and only with blood (three EDTA tubes) during the post-operative monitoring of the patients. This study is likely to include 320 post-operative patients treated with intravenous tramadol during one year in three university hospitals centers (CHU of Caen, Creteil and Rouen).

The first aim of this study is the validation of monitoring seric concentrations of O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor metabolizers in therapeutic situation, comparing the result with genotyping. The finding of a poor metabolizer status in a patient will make the choice of analgesic drugs easier, avoiding tramadol and codeine. The final objective of this research is to be able to determine the CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By a single take of blood and a rapid response, this method should be liked to improve pain management. Furthermore, CYP2D6 phenotyping is interesting for the patient because many other drugs depend on this way of metabolism.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

We propose to phenotype CYP2D6 in post-operative patients treated by tramadol by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in comparision with genotype, and to find a threeshold to determine poor metabolizers. As already described, genotyping CYP2D6 will use a rapid detection method of the alleles implicated in poor metabolizer status (CYP2D6*3, *4, *5 et *6) in a caucasian population

Non-Probability Sample

Post-operative patients treated by tramadol

Post-operative Patients Treated by Tramadol
Biological: Monitoring seric concentrations of O-demethyl-tramadol and tramadol
The first aim of this study is the validation of monitoring seric concentrations of O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor metabolizers in therapeutic situation, comparing the result with genotyping. The finding of a poor metabolizer status in a patient will make the choice of analgesic drugs easier, avoiding tramadol and codeine. The final objective of this research is to be able to determine the CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By a single take of blood and a rapid response, this method should be liked to improve pain management. Furthermore, CYP2D6 phenotyping is interesting for the patient because many other drugs depend on this way of metabolism.
  • Not Poor metabolizer
    Intervention: Biological: Monitoring seric concentrations of O-demethyl-tramadol and tramadol
  • Poor metabolizer
    Intervention: Biological: Monitoring seric concentrations of O-demethyl-tramadol and tramadol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
301
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age > 18 years, post-operative patient treated with intravenous tramadol
  • Caucasian origin
  • take of blood at H24 and H48 in the post-operative monitoring

Exclusion Criteria:

  • patient having already been included in the study
  • patient taking opioid drugs before surgery
  • patient taking one or more drugs inhibiting the CYP2D6 before or during surgery
  • pregnancy or breast feeding patients having one or more contraindications for taking tramadol in post-operative analgesia
  • hepatocellular incapacity (TP < 70%)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00952159
2009-A00380-57, 09-013
No
Patrick MICHEL (research and strategy manager), Caen University Hospital
University Hospital, Caen
Not Provided
Principal Investigator: Blandine de la Gastine, MD University Hospital, Caen
University Hospital, Caen
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP