Investigation of interindividual factors in fentanyl pharmacokinetics and clinical responses in Japanese cancer patients receiving transdermal fentanyl

Investigation of interindividual factors in fentanyl pharmacokinetics and clinical responses in Japanese cancer patients receiving transdermal fentanyl - Investigation of interindividual factors in fentanyl pharmacokinetics and clinical responses in Japanese cancer patients receiving transdermal fentanyl

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011284

Enrollment

100

Registered

2013-08-01

Start date

2013-08-01

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 transdermal fentanyl for cancer pain 2. Patients receiving written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients discontinuing transdermal fentanyl 2. Patients having severe kidney dysfunction or liver dysfunction 3. Patients who have a difficulty in determination of the 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 fentanyl and norfentanyl 192 hours and later starting transdermal fentanyl.	—

Secondary

Measure	Time frame
1. Genetic variants of ABCB1, CYP3A5, COMT, DRD2 and OPRM1 2. GPS score 3. Plasma prolactin level 4. Analgesic effect 5. Adverse reaction	—

Countries

Japan

Contacts

Public ContactTakafumi Naito

Hamamatsu University School of Medicine Department of Hospital Pharmacy

pharmacyham-adm@umin.ac.jp053-435-2623

Outcome results