UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031143 |
|---|---|
| Receipt number | R000035570 |
| Scientific Title | Analysis of pain and analgesics against oral mucositis in pediatric patients undergoing hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2021/08/09 07:24:59 |
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Basic information
Public title
Analysis of pain and analgesics against oral mucositis in pediatric patients undergoing hematopoietic stem cell transplantation
Acronym
Oral pain assessment in pediatric patients undergoing hematopoietic stem cell transplantation
Scientific Title
Analysis of pain and analgesics against oral mucositis in pediatric patients undergoing hematopoietic stem cell transplantation
Scientific Title:Acronym
Oral pain assessment in pediatric patients undergoing hematopoietic stem cell transplantation
Region
| Japan |
Condition
Condition
hematopoietic stem cell transplantation in pediatric patients
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of pain management against
oral mucositis due to hematopoietic stem cell transplantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency and dose of opioids agasint pain due to oral mucositis.
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
| 1 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients receiving hematopoietic stem cell transplantation
Key exclusion criteria
history of psychological or neurological disorders,
severe obesity (body mass index >35%)
cognitive impairment.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoshi Hosokawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pain Management and Palliative Care Medicine
Zip code
Address
Kajiicho 465 Kamigyo-Ku Kyoto
TEL
075-251-5177
hosobon@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chul Kwon |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pain Management and Palliative Care Medicine
Zip code
Address
Kajiicho 465 Kamigyo-Ku Kyoto
TEL
075-251-5177
Homepage URL
gon0410@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
Address
Tel
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
| 2020 | Year | 04 | 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
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 | 12 | Month | 27 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pain intensity and use of analgesics during the chemotherapy is investigated.
Management information
Registered date
| 2018 | Year | 02 | Month | 05 | Day |
Last modified on
| 2021 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035570
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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