Status:
COMPLETED
OXY-2: The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models
Lead Sponsor:
Odense University Hospital
Conditions:
Healthy
Eligibility:
All Genders
20-40 years
Phase:
PHASE4
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 CYP2D...
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...
Eligibility Criteria
Inclusion
- 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
- Any known allergy or intolerance to oxycodone.
- Regularly drug therapy or medication (except contraceptives).
- Alcohol or medicine abuse.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00271973
Start Date
February 1 2006
End Date
January 1 2007
Last Update
January 30 2007
Active Locations (1)
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1
University of Southern Denmark, IST Clinical Pharmacology
Odense, Odense C, Denmark, 5000