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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018954
Receipt No. R000021931
Scientific Title A quasi-randomized clinical trial of tapentadol versus oxycodone for initial control of moderate cancer-related pain
Date of disclosure of the study information 2015/09/09
Last modified on 2017/11/04

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Basic information
Public title A quasi-randomized clinical trial of tapentadol versus oxycodone for initial control of moderate cancer-related pain
Acronym A comparison of tapentadol and oxycodone for cancer pain
Scientific Title A quasi-randomized clinical trial of tapentadol versus oxycodone for initial control of moderate cancer-related pain
Scientific Title:Acronym A comparison of tapentadol and oxycodone for cancer pain
Region
Japan

Condition
Condition Malignant neoplasm
Classification by specialty
Not applicable Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This prospective study aims to investing the safety and efficacy of tapentadol and oxycodone for moderate cancer pain.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Analgesic effects after 2-4weeks later (NRS, STAS-J)
Adverse effect rate
Key secondary outcomes Efficacy rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral tapentadol (50-200 mg/day) was given until the initial sign of signify analgesia was detected by patients.
Interventions/Control_2 Oxycodone (10-40 mg) was given until the initial signs of signify analgesia was detected by patients.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with moderate cancer-related pain (NRS 3-8 and STAS-J 2-3)
Patients who agreed to participate in the study and signed informed consent form
Key exclusion criteria Patients with previously receiving strong opioid analgesic administration.
Patient with severe cancer-related pain (NRS 9-10 and/or STAS-J 4)
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuro Kato
Organization Kansai Electric Power Hospital
Division name Department of Palliative Medicine
Zip code
Address 2-1-7, Fukusima, Fukusima-ku, Osaka city, Osaka, 553-0003 Japan
TEL 06-6458-5821
Email kato.yasuro@d5.kepco.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuro Kato
Organization Kansai Electric Power Hospital
Division name Department of Palliative Medicine
Zip code
Address 2-1-7, Fukusima, Fukusima-ku, Osaka city, Osaka, 553-0003 Japan
TEL 06-6458-5821
Homepage URL
Email kato.yasuro@d5.kepco.co.jp

Sponsor
Institute Kansai Electric Power Hospital
Institute
Department

Funding Source
Organization Kansai Electric Power Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 関西電力病院(大阪府) 

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 09 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 Preinitiation
Date of protocol fixation
2015 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 09 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
2015 Year 09 Month 09 Day
Last modified on
2017 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021931

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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