UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046399 |
|---|---|
| Receipt number | R000052396 |
| Scientific Title | A retrospective study on the efficacy and safety of continuous subcutaneous hydromorphone titration for cancer pain |
| Date of disclosure of the study information | 2021/12/16 |
| Last modified on | 2021/12/16 23:45:56 |
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Basic information
Public title
A retrospective study on the efficacy and safety of continuous subcutaneous hydromorphone titration for cancer pain
Acronym
A retrospective study on continuous subcutaneous hydromorphone titration for cancer pain
Scientific Title
A retrospective study on the efficacy and safety of continuous subcutaneous hydromorphone titration for cancer pain
Scientific Title:Acronym
A retrospective study on continuous subcutaneous hydromorphone titration for cancer pain
Region
| Japan |
Condition
Condition
Moderate or severe, uncontrollable cancer pain.
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the efficacy and safety of the continuous subcutaneous hydromorphone titration for cancer pain retrospectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Completion rate of titration.
Key secondary outcomes
Time to completion of titration; response rate; effect on other symptoms including dyspnea; adverse events.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continuous subcutaneous injection of hydromorphone.
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
Moderate or severe, uncontrollable cancer pain.
Key exclusion criteria
None.
Target sample size
79
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Kajiyama |
Organization
The Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name
Department of palliative care
Zip code
530-8480
Address
2-4-20, Ougi-machi, Kita-ku, Osaka, Japan
TEL
06-6312-1221
t-kajiyama@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Tatsuma |
| Middle name | |
| Last name | Sakaguchi |
Organization
The Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name
Department of palliative care
Zip code
530-8480
Address
2-4-20, Ougi-machi, Kita-ku, Osaka, Japan
TEL
06-6312-1221
Homepage URL
t-sakaguchi@kitano-hp.or.jp
Sponsor or person
Institute
The Tazuke Kofukai Medical Research Institute, Kitano Hospital
Institute
Department
Personal name
Funding Source
Organization
The Tazuke Kofukai Medical Research Institute, Kitano 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
The Tazuke Kofukai Medical Research Institute, Kitano Hospital
Address
2-4-20, Ougi-machi, Kita-ku, Osaka, Japan
Tel
06-6312-1221
t-sakaguchi@kitano-hp.or.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
公益財団法人田附興風会医学研究所北野病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 16 | 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
37
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
| 2021 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2021 | Year | 12 | Month | 16 | Day |
Last modified on
| 2021 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052396
