UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056535 |
|---|---|
| Receipt number | R000064609 |
| Scientific Title | Examination of the effectiveness and complications of intrathecal pumps for giving opioids placed in patients with intractable cancer pain. |
| Date of disclosure of the study information | 2024/12/23 |
| Last modified on | 2024/12/23 10:22:24 |
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Basic information
Public title
Examination of the effectiveness and complications of intrathecal pumps for giving opioids placed in patients with intractable cancer pain.
Acronym
Examination of the effectiveness and complications of intrathecal pumps for giving opioids placed in patients with intractable cancer pain.
Scientific Title
Examination of the effectiveness and complications of intrathecal pumps for giving opioids placed in patients with intractable cancer pain.
Scientific Title:Acronym
Examination of the effectiveness and complications of intrathecal pumps for giving opioids placed in patients with intractable cancer pain.
Region
| Japan |
Condition
Condition
patients with intractable cancer pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness and complications of intrathecal pumps for giving opioids placed in patients with intractable cancer pain.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of pain and narcotic side effects after intrathecal pumps for giving opioids placement.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who had a intrathecal pumps for giving opioids placed for intractable cancer pain at our hospital from January 2022 to December 2024.
Key exclusion criteria
Research subjects judged by the research director or attending physician to be unsuitable for safely conducting this research.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Mishima |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Anesthesiology
Zip code
569-8686
Address
2-7 Daigaku-cho, Takatsuki City, Osaka 569-8686, Japan
TEL
072-683-1221
trad@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Mishima |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Anesthesiology
Zip code
569-8686
Address
2-7 Daigaku-cho, Takatsuki City, Osaka 569-8686, Japan
TEL
072-683-1221
Homepage URL
hiroki.mishima@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
not
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-cho, Takatsuki City, Osaka 569-8686, Japan
Tel
072-683-1221
trad@ompu.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
| 2024 | Year | 12 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective review based on medical records.
Management information
Registered date
| 2024 | Year | 12 | Month | 23 | Day |
Last modified on
| 2024 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064609
