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 | 2024/12/21 15:06:52 |
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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 | Tetsuya |
| Middle name | |
| Last name | Iijima |
Organization
University of Yamanashi
Division name
University of Yamanashi School of Medicine, Anesthesiology
Zip code
409-3898
Address
Yamanashi Chuo Shimogato 1110
TEL
0552-73-9690
tiijima@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Iijima |
Organization
University of Yamanashi
Division name
University of Yamanashi School of Medicine, Anesthesiology
Zip code
409-3898
Address
Yamanashi Chuo Shimogato 1110
TEL
0552-73-9690
Homepage URL
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
Ethics Committee, University of Yamanashi School of Medicine
Address
1110 Shimokawahigashi, Chuo City, Yamanashi Prefecture
Tel
0552731111
rec-med@yamanashi.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
| 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
Terminated
Date of protocol fixation
| 2013 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 01 | Day |
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
| 2024 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014589
