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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014951
Receipt No. R000017393
Scientific Title The study of postoperative intravenous patient-controlled (iv-PCA) analgesia used by oxycodone for Japanese Patients
Date of disclosure of the study information 2014/09/01
Last modified on 2018/08/23

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Basic information
Public title The study of postoperative intravenous patient-controlled (iv-PCA) analgesia used by oxycodone for Japanese Patients
Acronym The study of postoperative intravenous patient-controlled (iv-PCA) analgesia used by oxycodone for Japanese Patients
Scientific Title The study of postoperative intravenous patient-controlled (iv-PCA) analgesia used by oxycodone for Japanese Patients
Scientific Title:Acronym The study of postoperative intravenous patient-controlled (iv-PCA) analgesia used by oxycodone for Japanese Patients
Region
Japan

Condition
Condition malignant tumor
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Definition the protocol of iv-PCA used by oxycodone for Japanese patients(contains patients with renal disorder)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes improvement of pain
Key secondary outcomes respiratory depression,
nausea, vomiting, itching,
change of drug concentration between before and after hemodialysis

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Change postoperative analgesic agent to use for iv-PCA morphine hydrochloride to oxycodone hydrochloride
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Patients are performed elective operation under general anesthesia for malignant tumor or suspicion.
2. General status of patients are stable and classified into ASA 1 or 2.
(object cases for elimination efficacy by hemodialysis contain belong to class 3)
3.Patients choice iv-PCA as methods for postoperative analgesia.
4.Patients stay intensive care unit after surgery and continue direct measurement of arterial pressure.
Key exclusion criteria 1.Difficult patient to obtain consent or judge efficacy by mental disease or symptom.
2.Contrradicated cases for oxycodene hydrochloride (severe respiratory supression, COPD, heart failure, asthma attack, ileus, diarrhea).
3.The value of Hb is under 8mg/dl when the patient entersj intensive care unit.
4.The patient is judged to require blood transfusion after operation.
5.Also, the doctor determine the patient is inadequate to attend the study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koki Taira
Organization Jichi Medical University
Division name department of anesthesiology and critical care medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke-city, Tochigi prefecture, Japan
TEL +81-285-58-7383
Email ktaira@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koki Taira
Organization Jichi Medical University
Division name department of anesthesiology and critical care medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke-city, Tochigi prefecture, Japan
TEL +81-285-58-7383
Homepage URL
Email ktaira@jichi.ac.jp

Sponsor
Institute Jichi Medical University Hospital
Institute
Department

Funding Source
Organization None
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
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 自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 01 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
We terminated trial with no registered cases.There are two reasons for discontinuation.
1)Decreasing of candidate cases by the change of operating methods and postoperative management (many cases go back to ward directly without monitoring by artery-line that can use as blood sampling line)
2)By enactment of Clinical Trials Act, the usage restriction of oxycodone in this study arise (the possibility for regarding usage as Off-label use)
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 Enrolling by invitation
Date of protocol fixation
2014 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
2018 Year 08 Month 23 Day
Date of closure to data entry
2018 Year 08 Month 23 Day
Date trial data considered complete
2018 Year 08 Month 23 Day
Date analysis concluded
2018 Year 08 Month 23 Day

Other
Other related information

Management information
Registered date
2014 Year 08 Month 25 Day
Last modified on
2018 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017393

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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