Study on interindividual variability in pregabalin pharmacokinetics and pharmacodynamics in Japanese pain patients

Study on interindividual variability in pregabalin pharmacokinetics and pharmacodynamics in Japanese pain patients - Pregabalin PK-PD in Japanese pain patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000024568

Enrollment

100

Registered

2016-10-26

Start date

2015-04-01

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

Pain

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients receiving pregabalin for the treatment of pain 2.Patients who can give written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients discontinued the treatment of pregabalin 2.Patients having severe kidney dysfunction or liver dysfunction 3.Patients assessed as inappropriate for the study enrollment by the attending physician

Design outcomes

Primary

Measure	Time frame
Plasma concentrations of pregabalin at 96 hours or later after initiation of oral pregabalin therapy.	—

Secondary

Measure	Time frame
1.Analgesic effect (numerical rating scale) 2.Adverse reaction (dizziness, somnolence, dry mouth, edema, weight gain) 3.Renal function (estimated glomerular filtration rate, creatinine clearance) 4.GPS(glasgow prognostic score) 5.Classification of cancer cachexia (pre-cachexia, cachexia syndrome, refractory cachexia)	—

Countries

Japan

Contacts

Public ContactTakafumi Naito

Hamamatsu University School of Medicine Department of Hospital pharmacy

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

Outcome results