UMIN-CTR Clinical Trial

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

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013312
Receipt No. R000015532
Official scientific title of the study Establishment of mass spectrometric determination of drugs in hair and its application to forensic medicine and pharmacokinetic analysis
Date of disclosure of the study information 2014/03/03
Last modified on 2014/03/03

* 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
Official scientific title of the study Establishment of mass spectrometric determination of drugs in hair and its application to forensic medicine and pharmacokinetic analysis
Title of the study (Brief title) Establishment of mass spectrometric determination of drugs in hair and its application to forensic medicine and pharmacokinetic analysis
Region
Japan

Condition
Condition Drug abuse
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Establishment of a single hair analysis of drugs
Basic objectives2 Others
Basic objectives -Others Establishment of a single hair analysis of drugs by MALDI mass spectrometry imaging
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Estimation of drug-use history by visualizing drug distribution in hair
Key secondary outcomes Elucidation of the incorporation mechanism of drugs into hair by visualizing their distribution in hair

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 Educational,Counseling,Training
Type of intervention
Medicine
Interventions/Control_1 single or multiple administration
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
25 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria healthy volunteers
Key exclusion criteria expectant mothers
Target sample size 5

Research contact person
Name of lead principal investigator Khoichi Suzuki
Organization Legal Medicine
Division name Social Medicine
Address 2-7 Daigaku-cho Takatsuki, Osaka
TEL 072-681-1221
Email koichisz@art.osaka-med.ac.jp

Public contact
Name of contact person Hitoshi Tsuchihashi
Organization Osaka Medical College
Division name Legal Medicine
Address 2-7 Daigaku-cho Takatsuki, Osaka
TEL 0726-83-1221
Homepage URL
Email leg019@art.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Ministry od Education
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2014 Year 03 Month 03 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2013 Year 02 Month 14 Day
Anticipated trial start date
2013 Year 05 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 03 Month 03 Day
Last modified on
2014 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015532


Contact us.