UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039308 |
|---|---|
| Receipt number | R000044832 |
| Scientific Title | Investigation of tramadol pharmacokinetics and clinical responses in Japanese patients with head and neck cancer receiving oral tramadol |
| Date of disclosure of the study information | 2020/01/30 |
| Last modified on | 2024/04/04 11:11:36 |
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Basic information
Public title
Investigation of tramadol pharmacokinetics and clinical responses in Japanese patients with head and neck cancer receiving oral tramadol
Acronym
Investigation of tramadol pharmacokinetics and clinical responses in Japanese patients with head and neck cancer receiving oral tramadol
Scientific Title
Investigation of tramadol pharmacokinetics and clinical responses in Japanese patients with head and neck cancer receiving oral tramadol
Scientific Title:Acronym
Investigation of tramadol pharmacokinetics and clinical responses in Japanese patients with head and neck cancer receiving oral tramadol
Region
| Japan |
Condition
Condition
cancer pain
Classification by specialty
| Oto-rhino-laryngology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study evaluates the plasma dispositions of and the clinical response to tramadol based on the cachexia stage and genetic variants of drug metabolizing enzymes, drug transporters receiving oral tramadol.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentrations of tramadol, O-desmethyltramadol, N-desmethyltramadol and N,O-didesmethyltramadol 96 hours and later starting oral tramadol.
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
1. Patients receiving oral tramadol for pain
2. Patients receiving written informed consent
Key exclusion criteria
1. Patients discontinuing oral tramadol
2. Patients having severe kidney dysfunction or liver dysfunction
3. Patients who have a difficulty in determination of genotype using peripheral blood sample
4. Patients who are judged by physicians as inappropriate for study enrollment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Kawakami |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
TEL
053-435-2763
pharmacyham-adm@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Naito |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital pharmacy
Zip code
431-3192
Address
1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
TEL
053-435-2763
Homepage URL
pharmacyham-adm@umin.ac.jp
Sponsor or person
Institute
Department of Hospital pharmacy
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Hospital pharmacy
Hamamatsu University School of Medicine
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
Ethics Committee of Clinical Research
Address
1-20-1 Handayama, Hamamatsu, Shizuoka, Japan
Tel
053-435-2680
rinri@hama-med.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
| 2020 | Year | 01 | Month | 30 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:Observational study
Object recruitment:All patients who visit our hospital and meet the selection criteria from April 2014 to March 2019.
Primary outcome:Plasma concentration of tramadol, O-desmethyltramadol, N-desmethyltramadol and N,O-didesmethyltramadol 96 hours and later starting oral tramadol.
Secondary outcome:
1. GPS
2. Cachexia stage
3. Genetic variants of ABCB1, CYP2D6, CYP3A5, and OPRM1
4. Plasma proinflammatory cytokines level
5. Plasma prolactin level
6. Analgesic effect
7. Adverse reaction
8. Metabolic marker
Management information
Registered date
| 2020 | Year | 01 | Month | 29 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044832
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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