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

* 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 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


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

Value
https://center6.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