UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008450 |
|---|---|
| Receipt number | R000009901 |
| Scientific Title | Risk factor analysis for nausea and vomite induceded by narcotic drugs, multi center trial. |
| Date of disclosure of the study information | 2012/07/17 |
| Last modified on | 2014/04/10 22:19:18 |
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Basic information
Public title
Risk factor analysis for nausea and vomite induceded by narcotic drugs, multi center trial.
Acronym
Risk factor analysis for nausea and vomite induceded by narcotic drugs, multi center trial.
Scientific Title
Risk factor analysis for nausea and vomite induceded by narcotic drugs, multi center trial.
Scientific Title:Acronym
Risk factor analysis for nausea and vomite induceded by narcotic drugs, multi center trial.
Region
| Japan |
Condition
Condition
cancer pain
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate relating factors between narcotic drug induced nausea/vomit and Patient physical/mental background through a questionnaire survey.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We analyze correlation between Patient background factor and nausea/vomit incidence for 7days after narcotic drugs administration.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All malignant disease patients who have no further history of Narcotic drugs administration.
Histopathology stage : no restriction
Agreement document : required
Key exclusion criteria
Narcotic drugs only single administration. (Not routine use.)
Withdrawal administration except a reason of nausea/vomit.
History of Codeine phosphate , Tramadol Hydrochloride, Pentazocine, Buprenorphine administration.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ueda |
Organization
Itami City Hospital
Division name
Pharmacy
Zip code
Address
1-100 Koyaike Itami Hyogo, Japan
TEL
0727773773
ueda-itm@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ueda |
Organization
Itami City Hospital
Division name
Pharmacy
Zip code
Address
1-100 Koyaike Itami Hyogo, Japan
TEL
0727773773
Homepage URL
ueda-itm@umin.ac.jp
Sponsor or person
Institute
Hanshin Palliative Pharmacotherapy Network
Institute
Department
Personal name
Funding Source
Organization
Hanshin Palliative Pharmacotherapy Network
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 07 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyze correlation between Patient background factor and nausea/vomit incidence for 7days after narcotic drugs administration.
Management information
Registered date
| 2012 | Year | 07 | Month | 17 | Day |
Last modified on
| 2014 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009901
