UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009346 |
|---|---|
| Receipt number | R000010919 |
| Scientific Title | Effect of BMI and body fat percentage on pharmacokinetics and analgesic effect of fentanyl after trasndermal fentanyl patch administration |
| Date of disclosure of the study information | 2012/11/16 |
| Last modified on | 2012/11/16 22:24:07 |
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Basic information
Public title
Effect of BMI and body fat percentage
on pharmacokinetics and analgesic effect
of fentanyl after trasndermal fentanyl patch administration
Acronym
Effect of obesity on PK and PD of fentanyl patch
Scientific Title
Effect of BMI and body fat percentage
on pharmacokinetics and analgesic effect
of fentanyl after trasndermal fentanyl patch administration
Scientific Title:Acronym
Effect of obesity on PK and PD of fentanyl patch
Region
| Japan |
Condition
Condition
cancer-related pain
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify effects of BMI and body fat percentage on pharmacokinetics and analgesic effect of fentanyl after trasndermal fentanyl patch administration
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation ship between BMI and body fat percentatge, and dose and serum concentration of fentanyl
Key secondary outcomes
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
Administration of fentanyl patch and blood sampling
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) cancer-related pain
2) inpatients or outpatients
3) prescribed blood sampling is acceptable
4) age 20 years or higher
5) gave written informed concent
Key exclusion criteria
1) history of hypersensitivity to fentanyl patch
2) concomitant use of other opioids (except for rescue)
3) concomitant use of azole antifungi drugs or steroids pulse therapy
4) bone metastasis
5) palliative radiation therapy
6) sever liver disease (AST or ALT, 100 IU/L or higher)
7) sever kidney disease (BUN 25 mg/dl or higher, or serum creatinine 2.0 mg/dL or higher)
8) other situation that doctor decides
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Miyamoto |
Organization
Kanazawa University Hospital
Division name
Department of Pharmacy
Zip code
Address
13-1 Takara-machi, Kanazawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Sai |
Organization
Kanazawa University Hospital
Division name
Department of Pharmacy
Zip code
Address
TEL
Homepage URL
sai-ys@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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 | 11 | Month | 16 | 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
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | 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
Management information
Registered date
| 2012 | Year | 11 | Month | 16 | Day |
Last modified on
| 2012 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010919
