UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018954 |
|---|---|
| Receipt number | 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 23:13:35 |
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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
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
kato.yasuro@d5.kepco.co.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021931
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
