NCT02728648

Brief Summary

Oxycodone has been in clinical use for decades. It is an effective alternative to morphine for moderate to severe acute or chronic pain and has been found to improve quality of life. The drug has been used parenterally or orally as perioperative analgesia or for cancer pain relief. Despite its long clinical experience, prescribing errors and misuse may lead to addiction and accidental overdose. Currently, little is known about the pharmacokinetic properties of intravenous oxycodone among paediatric patients in this region even though the drug has been used in children in other countries such as Finland. Therefore, a pharmacokinetic-pharmacodynamic study of oxycodone among Malaysian pediatric patients is warranted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Apr 2016

Typical duration for phase_4 pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

1.6 years

First QC Date

March 25, 2016

Last Update Submit

January 12, 2022

Conditions

Pain

Keywords

Pain ManagementPharmacokineticsPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Clearance (CL)

    Clearance: volume of plasma from which oxycodone is completely removed per unit time;

    18 months

Secondary Outcomes (1)

  • Volume of distribution of IV oxycodone

    18 months

Study Arms (1)

Active

OTHER

Open label IV Oxycodone 0.1 mg/kg Bolus Pharmacokinetic-Pharmacodynamic Study

Drug: Oxycodone

Interventions

OxycodoneDRUG

Pain Management

Also known as: OxyNorm
Active

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 3 to 65 years
  • Generally healthy as documented by medical history (ASA 1-II)
  • Opioid-naïve
  • Patient is scheduled for a surgical procedure/procedures that is/are expected to require an analgesia with an opiate level medication.
  • Patient who will remain hospitalized for at least 24 hours after dosing with the study drug.
  • A negative urine pregnancy test at screening for females of childbearing potential

You may not qualify if:

  • Patient is a lactating or breastfeeding female
  • Patient has known allergy to oxycodone or any ingredient in oxycodone dosage form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, University of Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (4)

  • Kalso E, Poyhia R, Onnela P, Linko K, Tigerstedt I, Tammisto T. Intravenous morphine and oxycodone for pain after abdominal surgery. Acta Anaesthesiol Scand. 1991 Oct;35(7):642-6. doi: 10.1111/j.1399-6576.1991.tb03364.x.

    PMID: 1785245BACKGROUND

  • Olkkola KT, Hamunen K, Seppala T, Maunuksela EL. Pharmacokinetics and ventilatory effects of intravenous oxycodone in postoperative children. Br J Clin Pharmacol. 1994 Jul;38(1):71-6. doi: 10.1111/j.1365-2125.1994.tb04324.x.

    PMID: 7605420BACKGROUND

  • Poyhia R, Olkkola KT, Seppala T, Kalso E. The pharmacokinetics of oxycodone after intravenous injection in adults. Br J Clin Pharmacol. 1991 Oct;32(4):516-8. doi: 10.1111/j.1365-2125.1991.tb03942.x.

    PMID: 1958450BACKGROUND

  • Kokubun H, Yoshimoto T, Hojo M, Fukumura K, Matoba M. Pharmacokinetics of oxycodone after intravenous and subcutaneous administration in Japanese patients with cancer pain. J Pain Palliat Care Pharmacother. 2014 Dec;28(4):338-50. doi: 10.3109/15360288.2014.969872. Epub 2014 Oct 31.

    PMID: 25359452BACKGROUND

MeSH Terms

Conditions

PainAgnosia

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Sook Hui Chaw, M.Med

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 25, 2016

First Posted

April 5, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 28, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Oxycodone pharmacokinetics data

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After 5 years of study completion
Access Criteria
Request from primary investigator

Locations

MY(1)