Tramadol Clinical Efficiency and Tolerance Correlated to O-desmethyltramadol/Tramadol Ratio (CLINCYTRAM) (CLINCYTRAM)
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|ClinicalTrials.gov Identifier: NCT03357003|
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Tramadol is a grade II analgesics as World Health Organization definition. It can both be an agonist on mu receptors, which provides it a low opioid action, and also be a Serotonin-norepinephrine reuptake inhibitor, which act on neuropathic pain.
Tramadol is metabolized by P450 2D6 cytochrome (CYP2D6) in O-desmethyltramadol (O-dt) which is the most active form on the pharmacologic side (analgesic effect 2 to 4 times more powerful than tramadol itself).
In caucasian population, 5 to 10% of patients are genetically qualified as "poor metabolizer phenotype"; this status is correlated to a lower analgesic efficiency compared to "rapid metabolizer".
A multicenter study, CYTRAM, is under publication and allowed measurement of blood ratio O-dT/tramadol as a way to know the phenotype of CYP2D6 to detect "poor metabolizer phenotype" status.
Indeed, blood ratio O-dT/tramadol threshold under 0.1 detects " poor metabolizer phenotype " status for postoperative patients treated by tramadol, with a good sensibility (87,5%) and specificity (83.8%).
Which impacts for current practice? The next step is to know if this blood ratio is linked to an analgesic efficiency and a good tolerance for tramadol. A "poor metabolizer phenotype" patient would have no benefit of tramadol posology increasing. Therefore, phenotype detection, thank to blood ratio, could allow to switch quickly tramadol to another analgesic treatment for "poor metabolizer phenotype" patients.
The main objective of the study is to forge a link between O-dT/tramadol ratio and analgesic efficiency. Secondary objectives investigate side effects and frequency related to O-dT/tramadol ratio and pain relief, and also impact of CYP2D6 - inhibitor treatments on the blood ratio.
If there is a correlation between this blood ratio and treatment efficiency and tolerance, O-dT/tramadol ratio's detection will allow a better adaptation for some treatments metabolized by CYP2D6. Therefore, this evolution will contribute to health quality and health safety improvement.
|Condition or disease||Intervention/treatment|
|Pain||Other: Observational study|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Observational Study (and Blood Samples Without Genetics Analysis) Tramadol Clinical Efficiency and Tolerance Correlated to O-desmethyltramadol/Tramadol Ratio (CLINCYTRAM)|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||November 2018|
- Other: Observational study
Comparison between O-desmethyltramadol/tramadol ratio and tramadol clinical efficiency and tolerance
- Ratio measurement : O-desmethyltramadol blood concentration/ tramadol blood concentration [ Time Frame: at 48 hours ]
- visual analogic pain scale (1 to 10) [ Time Frame: at 48 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357003
|Contact: Anne Sophie Jossome, MD||02 31 06 31 06|
|Caen University Hospital||Recruiting|
|Contact: AS Jossomme, MD|