OXY-2: The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models
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|ClinicalTrials.gov Identifier: NCT00271973|
Recruitment Status : Completed
First Posted : January 4, 2006
Last Update Posted : January 30, 2007
|Condition or disease||Intervention/treatment||Phase|
|Healthy||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.
Electrical stimulation and cold pressor test are among the most well defined and evaluated human experimental pain models. The 32 volunteers will be submitted to the tests before and 1, 2, 3 and 4 hours after medicine intake.
To determine the plasma levels of Oxycodone and its metabolites blood will be drawn after each pain test. Also the CYP2D6 genotype and the above mentioned SNPs will be determined from the blood samples.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models|
|Study Start Date :||February 2006|
|Study Completion Date :||January 2007|
- Pain threshold and tolerance measured by electrical stimulation and pain intensity measured by cold pressor test.
- The above compared to SNPs. Plasma levels of oxycodone and metabolites.
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): NCT00271973
|University of Southern Denmark, IST Clinical Pharmacology|
|Odense, Odense C, Denmark, 5000|
|Principal Investigator:||Stine T. Zwisler, Dr.||University of Southern Denmark|