UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009346
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email sai-ys@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010919

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.