Unique ID issued by UMIN | UMIN000024568 |
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Receipt number | R000028276 |
Scientific Title | Study on interindividual variability in pregabalin pharmacokinetics and pharmacodynamics in Japanese pain patients |
Date of disclosure of the study information | 2016/10/26 |
Last modified on | 2020/11/16 11:42:38 |
Study on interindividual variability in pregabalin pharmacokinetics and pharmacodynamics in Japanese pain patients
Pregabalin PK-PD in Japanese pain patients
Study on interindividual variability in pregabalin pharmacokinetics and pharmacodynamics in Japanese pain patients
Pregabalin PK-PD in Japanese pain patients
Japan |
Pain
Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Cardiology | Pneumology | Endocrinology and Metabolism |
Hematology and clinical oncology | Nephrology | Neurology |
Clinical immunology | Psychosomatic Internal Medicine | Geriatrics |
Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Vascular surgery | Chest surgery | Endocrine surgery |
Breast surgery | Oto-rhino-laryngology | Orthopedics |
Urology | Radiology | Anesthesiology |
Oral surgery | Neurosurgery | Cardiovascular surgery |
Plastic surgery | Operative medicine |
Malignancy
YES
The aim of this study is to explore a factor affecting the interindividual variability in clinical responses to pregabalin.
PK,PD
Plasma concentrations of pregabalin at 96 hours or later after initiation of oral pregabalin therapy.
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)
Observational
Not applicable |
Not applicable |
Male and Female
1.Patients receiving pregabalin for the treatment of pain
2.Patients who can give written informed consent
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
100
1st name | Junichi |
Middle name | |
Last name | Kawakami |
Hamamatsu University School of Medicine
Department of Hospital pharmacy
431-3192
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
053-435-2762
pharmacyham-adm@umin.ac.jp
1st name | Takafumi |
Middle name | |
Last name | Naito |
Hamamatsu University School of Medicine
Department of Hospital pharmacy
431-3192
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
053-435-2623
pharmacyham-adm@umin.ac.jp
Department of Hospital pharmacy, Hamamatsu University School of Medicine
Department of Hospital pharmacy, Hamamatsu University School of Medicine
Self funding
Ethics Committee of Hamamatsu University School of Medicine
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
053-435-2111
rinri@hama-med.ac.jp
NO
2016 | Year | 10 | Month | 26 | Day |
Unpublished
Completed
2015 | Year | 03 | Month | 12 | Day |
2015 | Year | 03 | Month | 12 | Day |
2015 | Year | 04 | Month | 01 | Day |
2020 | Year | 11 | Month | 18 | Day |
Pregabalin dosage, analgesic effect (numerical rating scale), adverse reaction (dizziness, somnolence, dry mouth, edema, weight gain), and clinical laboratory values such as total protein, serum albumin, total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, blood urea nitrogen, serum creatinine, and C-reactive protein are collected to evaluate clinical responses during this study.
2016 | Year | 10 | Month | 26 | Day |
2020 | Year | 11 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028276
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