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Completed

NCT Number: NCT00271973

OXY-2: The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models

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.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Southern Denmark, IST Clinical Pharmacology

Odense, Odense C, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteer age between 20 and 40 years.
  • Healthy according to medical history and physical examination.
  • Informed consent given.
  • Phenotyped or genotyped as extensive or poor metabolizer of sparteine.
  • Female: Use of safe contraception (IUD, gestagen injectiones or oral contraceptive) or negative u-HCG test.

Exclusion criteria

  • Any known allergy or intolerance to oxycodone.
  • Regularly drug therapy or medication (except contraceptives).
  • Alcohol or medicine abuse.

Treatment and study plan

Oxycodone

Drug

Primary outcomes

  1. Pain threshold and tolerance measured by electrical stimulation and pain intensity measured by cold pressor test.

Secondary outcomes

  1. The above compared to SNPs. Plasma levels of oxycodone and metabolites.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models

Important dates

Study start
2006
Study completion
2007
First posted
Jan 4, 2006
Registry last updated
Jan 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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