UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003580
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

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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