Unique ID issued by UMIN | UMIN000003580 |
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Receipt number | R000004314 |
Scientific Title | Effect of Aprepitant on Pharmacokinecics of Controlled-Release Oxycodone |
Date of disclosure of the study information | 2010/06/01 |
Last modified on | 2020/01/04 17:33:19 |
Effect of Aprepitant on Pharmacokinecics of Controlled-Release Oxycodone
Effect of Aprepitant on Pharmacokinecics of Controlled-Release Oxycodone
Effect of Aprepitant on Pharmacokinecics of Controlled-Release Oxycodone
Effect of Aprepitant on Pharmacokinecics of Controlled-Release Oxycodone
Japan |
Cancer patients receiving controlled-release oxycodone
Hematology and clinical oncology |
Malignancy
NO
To ivestigate the effect of aprepitant on pharmacokinecics of controlled-release cxycodone
Pharmacokinetics
Exploratory
Explanatory
Not applicable
Pharmacokinetics of oxycodone and its metabolites with and without aprepitant administration
Safety, Adverse event, Effectiveness
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Pharmacokinetics of oxycodone and its metabolites with and without aprepitant administration
18 | years-old | <= |
Not applicable |
Male and Female
1. Patients with malignant solid tumors or hematological malignancy
2. age > 18 years
3. Patients receiving aprepitant for the prevention of chemotherapy induced nausea and vomiting.
4. Adequate hepatic and renal function
5. Written informed consent.
1. Patients requiring rescue use of Oxynorm
2. Concomitant medications of CYP3A4 strong inhibitors or inducers
3. Patients with malabsorption
4. Patients judged inappropriate for the study by the physicians
20
1st name | Hironobu |
Middle name | |
Last name | Minami |
Department of Medicine, Kobe University Hospital and Graduate School of Medicine
Medical Oncology/Hematology
650-0017
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
0783825111
hminami@med.kobe-u.ac.jp
1st name | Yutaka |
Middle name | |
Last name | Fujiwara |
Department of Medicine, Kobe University Hospital and Graduate School of Medicine
Medical Oncology/Hematology
650-0017
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
0783825111
fu_ji_@yahoo.co.jp
Medical Oncology/Hematology, Department of Medicine
Kobe University Hospital and Graduate School of Medicine
Medical Oncology/Hematology, Department of Medicine
Kobe University Hospital and Graduate School of Medicine
Self funding
Kobe University Hospital and Graduate School of Medicine
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
078-382-5111
rinri@med.kobe-u.ac.jp
NO
2010 | Year | 06 | Month | 01 | Day |
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0104215
Published
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0104215
20
Aprepitant increased the area under the plasma concentration time curve (AUC) of oxycodone by 25% (p<0.001) and of oxymorphone by 34% (p,0.001), as well as decreased the AUC of noroxycodone by 14% (p<0.001).
Moreover, aprepitant increased Css of oxycodone by 57% (p = 0.001) and of oxymorphone by 36% (p<0.001) and decreased
Css of noroxycodone by 24% (p = 0.02) at day 3 compared to day 1.
2020 | Year | 01 | Month | 04 | Day |
The subjects were enrolled in patients whom continued to be administered CR oxycodone twice or three times daily for cancer
pain and were planned to receive chemotherapy with aprepitant for CINV.
All patients provided written informed consent.
In this study and clinical practice, there was no increased incidence in pharmacologic effect and side effects of oxycodone due to concomitant use of aprepitant.
Aprepitant increased the area under the plasma concentration time curve (AUC) of oxycodone by 25% (p<0.001) and of oxymorphone by 34% (p,0.001), as well as decreased the AUC of noroxycodone by 14% (p<0.001).
Moreover, aprepitant increased Css of oxycodone by 57% (p = 0.001) and of oxymorphone by 36% (p<0.001) and decreased
Css of noroxycodone by 24% (p = 0.02) at day 3 compared to day 1.
Completed
2010 | Year | 06 | Month | 01 | Day |
2010 | Year | 06 | Month | 01 | Day |
2010 | Year | 07 | Month | 01 | Day |
2013 | Year | 05 | Month | 31 | Day |
2013 | Year | 05 | Month | 31 | Day |
2013 | Year | 05 | Month | 31 | Day |
2013 | Year | 11 | Month | 30 | Day |
2010 | Year | 05 | Month | 08 | Day |
2020 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004314
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