UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013635
Receipt number R000015915
Scientific Title the usefulness of a new simple drug test kit for acute drug intoxication
Date of disclosure of the study information 2014/04/04
Last modified on 2014/04/04 16:26:40

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Basic information

Public title

the usefulness of a new simple drug test kit for acute drug intoxication

Acronym

TOX study

Scientific Title

the usefulness of a new simple drug test kit for acute drug intoxication

Scientific Title:Acronym

TOX study

Region

Japan


Condition

Condition

acute drug intoxication

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

As screening purposes for the drug use of illegal drug use and patient patient drug high dosage, etc. is suspected, it is compared with the simple drug test kit that is currently in use, a new simple drug test kit that increased the inspection number of items, to clarify the usefulness of a new simple drug test kit.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The end point is the proof of the usefulness of new simple drug test kit (Triage TOX drug screen). Performing the comparison meaningful information is obtained or the patient care and subsequent test results when compared with the results simple drug test kits that are currently used (tri age DOA).

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

Patients who were judged of patients illegal drug use or drug overdose oral that is ambulance to International Medical Research Center Hospital is suspected, that there is a need to enforce the Tri-age DOA ® practice on.

Key exclusion criteria

none

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kentaro Kobayashi

Organization

National Center for Global Health and Medicine

Division name

Emergency Medicine and Critical Care

Zip code


Address

1-21-1 toyama Shinjuku-ku Tokyo

TEL

03-3202-7181

Email

baken1976@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kentaro Kobayashi

Organization

National Center for Global Health and Medicine

Division name

Emergency Medicine and Critical Care

Zip code


Address

1-21-1 toyama Shinjuku-ku Tokyo

TEL

03-3202-7181

Homepage URL


Email

baken1976@yahoo.co.jp


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

National Center for Global Health and Medicine

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)

alere medical Japan


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

2014 Year 04 Month 04 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

Open public recruiting

Date of protocol fixation

2014 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 04 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

Observations are as follows.
Characteristic of 1. Those surveyed (gender, age)
Various medical record description 2. History of present illness, past medical history, and oral history
3. Various clinical laboratory findings
(Tri-age DOA ®, Triage TOX drug screen) 4. Urinalysis findings
Final diagnosis 5. At presentation
Outcome of 6. Consultation after
Survey method is as follows.
Outpatient attending physician to fill in the data sheet for the target patient 1. Period.
I will extract the information from the medical records of study patients based on 2. Data sheet. Extraction Observations candidates are as follows.
Final diagnosis (head CT, head MRI), at presentation, outcome ((Tri-age DOA, Triage TOX drug screen blood test findings, cerebrospinal fluid examination findings, urinalysis findings)), various image laboratory findings various clinical laboratory findings
The aggregated information that is not connected from the anonymized information 3. Extraction and analyzes.


Management information

Registered date

2014 Year 04 Month 04 Day

Last modified on

2014 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015915


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name