OXY-1: The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain
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|ClinicalTrials.gov Identifier: NCT00260260|
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : January 11, 2008
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Oxycodone||Phase 4|
Oxycodone is a semi-synthetic opioid with an analgesic effect in the postoperative pain management comparable to morphine. Oxycodone is N-demethylated by CYP2D6 to its active metabolite oxymorphone, a potent μ-receptor agonist. A genetic polymorphism divides a Caucasian population into two groups: 8% with an enzyme lacking activity, poor metabolizers (PM) and the rest with normal CYP2D6 activity, extensive metabolizers (EM).
Many different, single nucleotide polymorphisms (SNPs) are responsible for interindividual differences in the effect of opioids. Among these are the A118G SNP in the μ-receptor gene OPRM1 and the C3435T and G2677T/A SNPs in the MDR-1 gene of P-glycoprotein. P-glycoprotein is responsible for the absorption, excretion and transport of many drugs including opioids over the blood-brain barrier.
The patients will receive the first Oxycodone dosis of 5 mg iv at the end of the surgery. If their pain is not sufficiently relieved they can be given maximum two times Oxycodone 5 mg iv in the recovery room. If still not sufficiently pain relieved they will be given escape medication (Morphine 5 mg iv) until sufficient pain relief.
Further pain treatment will be by Patient Controlled Analgesia (PCA) with bolus doses of Oxycodone 2 mg iv.
During the first 24 hours postoperatively the patients pain and side effects will be registered.
Three blood samples will be drawn: 1. approximately 30 minutes after first Oxycodone dosis, 2. before leaving the recovery room a couple of hours after surgery and 3. 24 hours after surgery. From these samples plasma levels of Oxycodone and its metabolites will be determined and the genotype of CYP2D6 and the above mentioned SNPs will be determined.
The patients will be divided into two groups: Responder and Non-responder. The Responders are characterized by no use of escape medication (morphine) and satisfaction with pain management in final questionnaire. The Non-responders are characterized by use of escape medicine and/or dissatisfaction with pain management in final questionnaire.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- Responder (satisfaction with pain treatment in questionnaire and no escape medication)
- Non-responder (dissatisfaction with pain management in questionnaire and/or escape medication)
- Responder status compared to CYP2D6 genotype
- Registration of pain, side effects and total amount of oxycodone given compared to CYP2D6 genotype and SNPs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260260
|Odense University Hospital|
|Odense C, Odense, Denmark, DK-5000|
|Principal Investigator:||Stine T. Zwisler, Dr.||University of Southern Denmark|