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Recruitment status Terminated
Unique ID issued by UMIN UMIN000031143
Receipt No. 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

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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
Email 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
Email gon0410@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035570

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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