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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
Sponsor:
Information provided by:
Odense University Hospital

Study Description
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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.


Study Design
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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

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Arms and Interventions
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Outcome Measures
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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.

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

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.
Contacts and Locations
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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


Locations
Denmark
University of Southern Denmark, IST Clinical Pharmacology
Odense, Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Stine T. Zwisler, Dr. University of Southern Denmark
More Information
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ClinicalTrials.gov Identifier: NCT00271973     History of Changes
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:
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents