Unique ID issued by UMIN | UMIN000020723 |
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Receipt number | R000019308 |
Scientific Title | Investigation of interindividual factors in oxycodone pharmacokinetics and clinical responses in Japanese cancer patients receiving oral oxycodone |
Date of disclosure of the study information | 2016/01/25 |
Last modified on | 2016/01/28 11:11:20 |
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
Investigation of interindividual factors in oxycodone pharmacokinetics and clinical responses in Japanese cancer patients receiving oral oxycodone
Japan |
cancer pain
Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Pneumology | Hematology and clinical oncology | Nephrology |
Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
Breast surgery | Obstetrics and Gynecology | Pediatrics |
Dermatology | Oto-rhino-laryngology | Orthopedics |
Urology | Radiology | Oral surgery |
Neurosurgery |
Malignancy
YES
This study evaluates the plasma dispositions of and the clinical response to oxycodone based on the cachexia stage and genetic variants of drug metabolizing enzymes, drug transporters receiving oral oxycodone.
PK,PD
Plasma concentration of oxycodone, noroxycodone, oxymorphone and noroxymorphone 192 hours and later starting oral oxycodone.
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
Observational
Not applicable |
Not applicable |
Male and Female
1. Patients receiving oral oxycodone for cancer pain
2. Patients receiving written informed consent
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
100
1st name | |
Middle name | |
Last name | Junichi Kawakami |
Hamamatsu University School of Medicine
Department of Hospital pharmacy
1-20-1 Handayama, Hamamatsu 431-3192
053-435-2763
pharmacyham-adm@umin.ac.jp
1st name | |
Middle name | |
Last name | Takafumi Naito |
Hamamatsu University School of Medicine
Department of Hospital pharmacy
1-20-1 Handayama, Hamamatsu 431-3192
053-435-2763
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
NO
2016 | Year | 01 | Month | 25 | Day |
Unpublished
Enrolling by invitation
2014 | Year | 05 | Month | 01 | Day |
2014 | Year | 07 | Month | 11 | Day |
Study design:Observational study
Object recruitment:All patients who visit our hospital and meet the selection criteria from July 2014 to March 2019.
Primary outcome:Plasma concentration of oxycodone, noroxycodone, oxymorphone and noroxymorphone 192 hours and later starting oral oxycodone.
Secondary outcome:
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
2016 | Year | 01 | Month | 25 | Day |
2016 | Year | 01 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019308
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