UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016414 |
|---|---|
| Receipt number | R000018981 |
| Scientific Title | Effect of tapentadol for the cancer pain |
| Date of disclosure of the study information | 2015/02/02 |
| Last modified on | 2015/02/02 12:35:53 |
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Basic information
Public title
Effect of tapentadol for the cancer pain
Acronym
tapentadol for the cancer pain
Scientific Title
Effect of tapentadol for the cancer pain
Scientific Title:Acronym
tapentadol for the cancer pain
Region
| Japan |
Condition
Condition
cancer patients
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study of effectiveness and safety of tapentadol for the neuropathic pain or nociceptive pain in cancer patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Comparison of pain NRS scores between neuropathic pain and nociceptive pain
Key secondary outcomes
Comparison of tapentadol doses between neuropathic pain or nociceptive pain
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tapentadol
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
cancer patients with cancer related pain with four or more NRS score of pain
Key exclusion criteria
1) bad controlled liver, kidney, heart, lung , hypertension and infectious diseases
2) psychiatric diseases including depression
3) pregnancy or breast-feeding
4) intake of SNRI inhibitor
5) the cases whom the doctor decide not to be the indication
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Hirayama |
Organization
Higashi Sapporo Hospital
Division name
Department of Hematology Oncology
Zip code
Address
Shiroishiku Higashisapporo 3-3, Sapporo
TEL
011-812-2311
hirayama@hsh.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Hirayama |
Organization
Higashi Sapporo Hospital
Division name
Department of Hematology Oncology
Zip code
Address
Shiroishiku Higashisapporo 3-3, Sapporo
TEL
011-812-2311
Homepage URL
hirayama@hsh.or.jp
Sponsor or person
Institute
Higashi Sapporo Hospital
Institute
Department
Personal name
Funding Source
Organization
Higashi Sapporo Hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 02 | 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 | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 10 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 20 | Day |
Other
Other related information
If the patients number was below the 80, we can prolong the duration of the study.
Management information
Registered date
| 2015 | Year | 02 | Month | 02 | Day |
Last modified on
| 2015 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018981
| 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 |
