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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003580
Receipt No. 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

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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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