Unique ID issued by UMIN | UMIN000011284 |
---|---|
Receipt number | R000012980 |
Scientific Title | Investigation of interindividual factors in fentanyl pharmacokinetics and clinical responses in Japanese cancer patients receiving transdermal fentanyl |
Date of disclosure of the study information | 2013/08/01 |
Last modified on | 2014/03/11 09:51:25 |
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
Investigation of interindividual factors in fentanyl pharmacokinetics and clinical responses in Japanese cancer patients receiving transdermal fentanyl
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 fentanyl based on the cachexia stage and genetic variants of drug metabolizing enzymes, drug transporters and drug receptors in cancer patients receiving transdermal fentanyl.
PK,PD
Plasma concentration of fentanyl and norfentanyl 192 hours and later starting transdermal fentanyl.
1. Genetic variants of ABCB1, CYP3A5, COMT, DRD2 and OPRM1
2. GPS score
3. Plasma prolactin level
4. Analgesic effect
5. Adverse reaction
Observational
Not applicable |
Not applicable |
Male and Female
1. Patients receiving transdermal fentanyl for cancer pain
2. Patients receiving written informed consent
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
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, Japan
053-435-2623
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
053-435-2623
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
NO
2013 | Year | 08 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2013 | Year | 03 | Month | 21 | Day |
2013 | Year | 08 | Month | 01 | Day |
To evaluate the plasma dispositions of and the clinical response to
fentanyl and norfentanyl based on the cachexia stage and genetic variants of drug metabolizing enzymes and drug transporters and drug receptors
2013 | Year | 07 | Month | 26 | Day |
2014 | Year | 03 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012980
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |