NCT00271973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
28 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

January 30, 2007

Status Verified

January 1, 2007

First QC Date

January 3, 2006

Last Update Submit

January 29, 2007

Conditions

Healthy

Outcome Measures

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.

Interventions

OxycodoneDRUG

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark, IST Clinical Pharmacology

Odense, Odense C, 5000, Denmark

Location

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Stine T. Zwisler, Dr.

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 4, 2006

Study Start

February 1, 2006

Study Completion

January 1, 2007

Last Updated

January 30, 2007

Record last verified: 2007-01

Locations

DK(1)