Investigation of interindividual factors in oxycodone pharmacokinetics and clinical responses in Japanese cancer patients receiving oral oxycodone

Investigation of interindividual factors in oxycodone pharmacokinetics and clinical responses in Japanese cancer patients receiving oral oxycodone - Investigation of interindividual factors in oxycodone pharmacokinetics and clinical responses in Japanese cancer patients receiving oral oxycodone

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000020723

Enrollment

100

Registered

2016-01-25

Start date

2014-07-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer pain

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients receiving oral oxycodone for cancer pain 2. Patients receiving written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients discontinuing oral oxycodone 2. Patients having severe kidney dysfunction or liver dysfunction 3. Patients who have a difficulty in determination of genotype using peripheral blood sample 4. Patients who are judged by physicians as inappropriate for study enrollment

Design outcomes

Primary

Measure	Time frame
Plasma concentration of oxycodone, noroxycodone, oxymorphone and noroxymorphone 192 hours and later starting oral oxycodone.	—

Secondary

Measure	Time frame
1. GPS 2. Cachexia stage 3. Genetic variants of ABCB1, CYP3A5, CYP2D6 and OPRM1 4. Plasma proinflammatory cytokines level 5. Plasma prolactin level 6. Analgesic effect 7. Adverse reaction 8. Metabolic marker	—

Countries

Japan

Contacts

Public ContactTakafumi Naito

Hamamatsu University School of Medicine Department of Hospital pharmacy

pharmacyham-adm@umin.ac.jp053-435-2763

Outcome results