UMIN-CTR Clinical Trial

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
Email	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
Email	takaomik@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama city university
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050579