UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046588 |
|---|---|
| Receipt number | R000053145 |
| Scientific Title | Continuous subcutaneous injection of fentanyl for titration of cancer pain: a retrospective study |
| Date of disclosure of the study information | 2022/02/15 |
| Last modified on | 2022/01/08 10:37:38 |
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Basic information
Public title
Continuous subcutaneous injection of fentanyl for titration of cancer pain: a retrospective study
Acronym
Continuous subcutaneous injection of fentanyl
Scientific Title
Continuous subcutaneous injection of fentanyl for titration of cancer pain: a retrospective study
Scientific Title:Acronym
Continuous subcutaneous injection of fentanyl
Region
| Japan |
Condition
Condition
Moderate to severe cancer pain
Classification by specialty
| Geriatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness and safety of continuous subcutaneous injection (CSCI) fentanyl titration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of titration completion.
Key secondary outcomes
Perioid of titration. Rate of more than 66% response of average numerical rating scale (NRS) of pain.
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 | Maneuver |
Interventions/Control_1
CSCI of fentanyl (less than 2 weeks).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
To have moderate to severe cancer pain.
Key exclusion criteria
non-titration purpose, non-cancer pain, and mild pain NRS less than 5.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Kajiyama |
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division name
Division of palliative care
Zip code
530-8480
Address
2-4-20, Ougi-machi, Kita-ku, Osaka, Japan
TEL
0663121221
t-kajiyama@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Tatsuma |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division name
Division of palliative care
Zip code
530-8480
Address
2-4-20, Ogimachi, Kita-ku, Osaka, 530-8480, Japan
TEL
0663121221
Homepage URL
sakaguchi.tatsuma@gmail.com
Sponsor or person
Institute
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Kitano Hospital, Tazuke Kofukai Medical Research Institute
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
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Address
2-4-20, Ougi-machi, Kita-ku, Osaka, Japan
Tel
0663121221
sakaguchi.tatsuma@gmail.com
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
公益財団法人田附興風会医学研究所北野病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 15 | 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
33
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
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 08 | Day |
Last modified on
| 2022 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053145
