UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012569
Receipt number R000014589
Scientific Title Examination of blood concentration change of each drug in patient-controlled analgesia with oxycodone ketamine lidocaine
Date of disclosure of the study information 2013/12/13
Last modified on 2020/06/18 12:02:37

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Examination of blood concentration change of each drug in patient-controlled analgesia with oxycodone ketamine lidocaine

Acronym

Correlation effects and blood levels of oxycodone, ketamine, lidocaine

Scientific Title

Examination of blood concentration change of each drug in patient-controlled analgesia with oxycodone ketamine lidocaine

Scientific Title:Acronym

Correlation effects and blood levels of oxycodone, ketamine, lidocaine

Region

Japan


Condition

Condition

Cancer pain

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Blood concentration measurement of oxycodone, ketamine, lidocaine

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation of oxycodone, ketamine, lidocaine blood concentrations and oxycodone, ketamine, lidocaine consumption

Key secondary outcomes



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

Intravenous administration of oxycodone, ketamine, lidocaine

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

At 20 years old or more, patients with cancer pain who are adaptive intravenous PCA with oxycodone injection

Key exclusion criteria

Patients using opioids at the time of recruitment

Patients who can not use the PCA pump

Patients with severe renal disease, severe liver disease, severe respiratory disease, severe heart disease


Patients are allergic to oxycodone, lidocaine, ketamin

Patients who are considered by the attending physician unsuitable for the present test

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Iijima

Organization

University of Yamanashi

Division name

University of Yamanashi School of Medicine, Anesthesiology

Zip code


Address

Yamanashi Chuo Shimogato 1110

TEL

0552-73-9690

Email

tiijima@yamanashi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuya Iijima

Organization

University of Yamanashi

Division name

University of Yamanashi School of Medicine, Anesthesiology

Zip code


Address

Yamanashi Chuo Shimogato 1110

TEL

0552-73-9690

Homepage URL


Email

tiijima@yamanashi.ac.jp


Sponsor or person

Institute

University of Yamanashi School of Medicine, Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

Shionogi & Company, Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2013 Year 12 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2013 Year 03 Month 31 Day

Date of IRB


Anticipated trial start date

2013 Year 04 Month 01 Day

Last follow-up date

2013 Year 12 Month 31 Day

Date of closure to data entry

2013 Year 12 Month 31 Day

Date trial data considered complete

2013 Year 12 Month 31 Day

Date analysis concluded

2014 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 12 Month 13 Day

Last modified on

2020 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014589


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name