Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00271973
Status:
COMPLETED
Last Update Posted:
2007-01-30
First Post:
2006-01-03
Brief Title:
OXY-2 The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Thirty-two healthy volunteers will be submitted to experimental pain and on the 2 study days receive Oxycodone 20 mg po vs placebo Half of the volunteers will be poor metabolizers according to CYP2D6 genotype and half will be extensive metabolizers EM and have an enzyme with normal function The study hypothesis is that PM will experience less pain relief than EM
Detailed Description:
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 G2677TA 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
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 G2677TA 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None