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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00271973
Recruitment Status : Completed
First Posted : January 4, 2006
Last Update Posted : January 30, 2007
Information provided by:
Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Oxycodone Phase 4

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 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models
Study Start Date : February 2006
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Pain threshold and tolerance measured by electrical stimulation and pain intensity measured by cold pressor test.

Secondary Outcome Measures :
  1. The above compared to SNPs. Plasma levels of oxycodone and metabolites.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00271973

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University of Southern Denmark, IST Clinical Pharmacology
Odense, Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
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Principal Investigator: Stine T. Zwisler, Dr. University of Southern Denmark
Layout table for additonal information Identifier: NCT00271973    
Other Study ID Numbers: EudraCT 2005-004082-42
First Posted: January 4, 2006    Key Record Dates
Last Update Posted: January 30, 2007
Last Verified: January 2007
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents