UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044282 |
|---|---|
| Receipt number | R000050579 |
| Scientific Title | A retrospective multicenter study to determine the clinical characteristics of tapentadol |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2021/12/24 13:01:40 |
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Basic information
Public title
A multicenter study on the safety of tapentadol
Acronym
A study on the safety of tapentadol
Scientific Title
A retrospective multicenter study to determine the clinical characteristics of tapentadol
Scientific Title:Acronym
A retrospective multicenter study on tapentadol
Region
| Japan |
Condition
Condition
Cancer pain
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To understand the safety and clinical characteristics of tapentadol
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of discontinuation of medication due to adverse events
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with carcinoma who started taking tapentadol from August 18th, 2014 to October 31th, 2019.
Key exclusion criteria
1) Patients for whom the start date of tapentadol is unknown
2) Patients deemed inappropriate for inclusion at the discretion of the principal investigator or sub-investigator
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kessoku |
| Middle name | |
| Last name | Takaomi |
Organization
Yokohama City University Hospital
Division name
Department of Palliative Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan.
TEL
0457872800
takaomik@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kessoku |
| Middle name | |
| Last name | Takaomi |
Organization
Yokohama City University Hospital
Division name
Department of Palliative Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan.
TEL
0457872800
Homepage URL
takaomik@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university
Institute
Department
Personal name
Funding Source
Organization
None
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
Yokohama city university, Institutional Review Board for Medical and Health Research Involving Human Subjects
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
Tel
0457872640
rinri@yokohama-cu.ac.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2019 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoint: Percentage of patients who discontinued treatment due to adverse events
The data for the cases to be analyzed will be extracted from the medical records of the relevant patients at each facility, and a separate database for analysis will be created. Retrospective analysis will be performed using the data for this study extracted at each facility.
Management information
Registered date
| 2021 | Year | 05 | Month | 21 | Day |
Last modified on
| 2021 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050579
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
