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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024060
Receipt No. R000027704
Scientific Title Investigation of intereindividual factors in tramadol pharmacokinetics and clinical responses in Japanese pain patients receiving oral tramadol
Date of disclosure of the study information 2016/09/15
Last modified on 2016/09/14

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Basic information
Public title Investigation of intereindividual factors in tramadol pharmacokinetics and clinical responses in Japanese pain patients receiving oral tramadol
Acronym Investigation of intereindividual factors in tramadol pharmacokinetics and clinical responses in Japanese pain patients receiving oral tramadol
Scientific Title Investigation of intereindividual factors in tramadol pharmacokinetics and clinical responses in Japanese pain patients receiving oral tramadol
Scientific Title:Acronym Investigation of intereindividual factors in tramadol pharmacokinetics and clinical responses in Japanese pain patients receiving oral tramadol
Region
Japan

Condition
Condition pain
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Obsterics and gynecology Dermatology
Oto-rhino-laryngology Orthopedics Urology
Radiology Anesthesiology Oral surgery
Neurosurgery Cardiovascular surgery Plastic surgery
Intensive care medicine
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

Not applicable
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
Middle name
Last name Junichi Kawakami
Organization Hamamatsu University School of Medicine
Division name Department of Hospital pharmacy
Zip code
Address 1-20-1 Handayama, Hamamatsu 431-3192
TEL 053-435-2763
Email pharmacyham-adm@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takafumi Naito
Organization Hamamatsu University School of Medicine
Division name Department of Hospital pharmacy
Zip code
Address 1-20-1 Handayama, Hamamatsu 431-3192
TEL 053-435-2763
Homepage URL
Email pharmacyham-adm@umin.ac.jp

Sponsor
Institute Department of Hospital pharmacy
Hamamatsu University School of Medicine
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 15 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 Enrolling by invitation
Date of protocol fixation
2014 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 20 Day
Last follow-up date
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 2017.

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
2016 Year 09 Month 14 Day
Last modified on
2016 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027704

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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