UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Aprepitant on Pharmacokinecics of Controlled-Release Oxycodone
Acronym	Effect of Aprepitant on Pharmacokinecics of Controlled-Release Oxycodone
Scientific Title	Effect of Aprepitant on Pharmacokinecics of Controlled-Release Oxycodone
Scientific Title:Acronym	Effect of Aprepitant on Pharmacokinecics of Controlled-Release Oxycodone
Region	Japan

Condition
Condition	Cancer patients receiving controlled-release oxycodone
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To ivestigate the effect of aprepitant on pharmacokinecics of controlled-release cxycodone
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Pharmacokinetics of oxycodone and its metabolites with and without aprepitant administration
Key secondary outcomes	Safety, Adverse event, Effectiveness

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pharmacokinetics of oxycodone and its metabolites with and without aprepitant administration
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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.
Key exclusion criteria	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
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hironobu Middle name Last name Minami
Organization	Department of Medicine, Kobe University Hospital and Graduate School of Medicine
Division name	Medical Oncology/Hematology
Zip code	650-0017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	0783825111
Email	hminami@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Yutaka Middle name Last name Fujiwara
Organization	Department of Medicine, Kobe University Hospital and Graduate School of Medicine
Division name	Medical Oncology/Hematology
Zip code	650-0017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	0783825111
Homepage URL
Email	fu_ji_@yahoo.co.jp

Sponsor
Institute	Medical Oncology/Hematology, Department of Medicine Kobe University Hospital and Graduate School of Medicine
Institute
Department

Funding Source
Organization	Medical Oncology/Hematology, Department of Medicine Kobe University Hospital and Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University Hospital and Graduate School of Medicine
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
Tel	078-382-5111
Email	rinri@med.kobe-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 01 Day

Related information
URL releasing protocol	https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0104215
Publication of results	Published

Result
URL related to results and publications	https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0104215
Number of participants that the trial has enrolled	20
Results	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.
Results date posted	2020 Year 01 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	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.
Participant flow	All patients provided written informed consent.
Adverse events	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.
Outcome measures	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.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 06 Month 01 Day
Date of IRB	2010 Year 06 Month 01 Day
Anticipated trial start date	2010 Year 07 Month 01 Day
Last follow-up date	2013 Year 05 Month 31 Day
Date of closure to data entry	2013 Year 05 Month 31 Day
Date trial data considered complete	2013 Year 05 Month 31 Day
Date analysis concluded	2013 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date	2010 Year 05 Month 08 Day
Last modified on	2020 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004314

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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