UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033981 |
|---|---|
| Receipt number | R000022257 |
| Scientific Title | Dexamethasone for the prophylaxis of radiation-induced pain flare after palliative radiotherapy for bone metastases:a phase 2 study. |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2018/09/01 10:04:08 |
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Basic information
Public title
Dexamethasone for the prophylaxis of radiation-induced pain flare after palliative radiotherapy for bone metastases:a phase 2 study.
Acronym
Dexamethasone for the prophylaxis of pain flare after radiotherapy for bone metastases
Scientific Title
Dexamethasone for the prophylaxis of radiation-induced pain flare after palliative radiotherapy for bone metastases:a phase 2 study.
Scientific Title:Acronym
Dexamethasone for the prophylaxis of pain flare after radiotherapy for bone metastases
Region
| Japan |
Condition
Condition
bone metastases
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Determing the usufullness of dexamethasone for the prophylaxis of radiation-induced pain flare after palliative radiotherapy for bone metastases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigating of the change of pain after taking of dexamethasone.
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
dexamethasone
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient who gave written informed concent.
Key exclusion criteria
The patient who do not informed concent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Tanaka |
Organization
Gifu Municipal Hospital
Division name
Radiation Oncology
Zip code
Address
7-1 Kashima-cho Gifu
TEL
81-58-251-1101
osa0508@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Tanaka |
Organization
Gifu Municipal Hospital
Division name
Radiation Oncology
Zip code
Address
7-1 Kashima-cho Gifu
TEL
81-58-251-1101
Homepage URL
osa0508@yahoo.co.jp
Sponsor or person
Institute
Gifu Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Gifu Municipal Hospital
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
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
| 2018 | 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
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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 01 | Day |
Last modified on
| 2018 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022257
