Study on interindividual variability in naldemedine pharmacokinetics, pharmacodynamics and tolerability in patients treated with opioids

Study on interindividual variability in naldemedine pharmacokinetics, pharmacodynamics and tolerability in patients treated with opioids - Naldemedine PK-PD and tolerability in patients treated with opioids

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000042675

Enrollment

250

Registered

2020-12-10

Start date

2020-12-10

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

opioid induced constipation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients taking naldemedine for the treatment of opioid induced constipation 2.Patients from whom written informed consents were obtained

Exclusion criteria

Exclusion criteria: 1. Patients having severe kidney or liver dysfunction 2. Patients assessed as inappropriate for the study enrollment by the attending physician

Design outcomes

Primary

Measure	Time frame
Plasma concentrations of naldemedine at 96 hours or later after initiation of naldemedine treatment	—

Secondary

Measure	Time frame
1. laxative effect (stool frequency, Bristol stool form scale) 2. genotyping (ABCB1, CYP2D6, CYP3A5) 3. pharmacokinetics of opioids 4. Adverse reaction (diarrhea, somnolence, nausea)	—

Countries

Japan

Contacts

Public ContactNakatsugawa Emi

Hamamatsu University School of Medicine Department of Hospital Pharmacy

naka.e@hama-med.ac.jp053-435-2763

Outcome results