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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002084
Receipt No. R000002535
Scientific Title 14C-acetaminophen microdose clinical trial using AMS
Date of disclosure of the study information 2009/06/21
Last modified on 2009/07/17

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Basic information
Public title 14C-acetaminophen microdose clinical trial using AMS
Acronym 14C-acetaminophen microdose clinical trial using AMS
Scientific Title 14C-acetaminophen microdose clinical trial using AMS
Scientific Title:Acronym 14C-acetaminophen microdose clinical trial using AMS
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to validate the methodology of AMS microding study including separeation and detection of 14C labeled parent compound and metabolites of acetaminophen
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes detection from radioactive concentraions of plasma, urin and feces samples.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 coadministration of acetaminophen and probenecid
Interventions/Control_2 administration of acetaminophen alone
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
45 years-old >
Gender Male
Key inclusion criteria the investigors must ensure that all subjects being considerd meet the following inclusion criteria
1) capable to understand and sign the informed consent.
2) 20-45 years of age
3)BMI 18.5-25.0
4)good health as determined by physical examination, vital signs and laboartory tests.
Key exclusion criteria the investigors must ensure that all subjects being considerd meet the following exclusion criteria or conditions
1)peptic ulcer
2)dysemia
3)kidney stone
4)history of cardiac disease
5)imparment of liver or kidney functions
6)any medical condition that reqires medical attention
7) recent (past 4 months) participation in other clinical trial and the investigator determines this trial participation inadequate
8)history of allergy to acetaminophen and probenecid
9)history of aspirin indeced asthma
10)donation of 400mL or more of blood within 3 months prior to participation, donation of 200mL or more of blood within 1 month prior to participation, or donation of component blood within 2 weeks prior to participation
11)positive serologic reaction of syphilis, positive result of HIV test, HBsAg and HCVAb
12)history of multiple and recurring allergies to medicines or food
13)history of drug or alcoholabuse
14) the investigator determines this trial participation inadequate
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ippei Ikushima
Organization Medical Co.LTA Honjo Clinic
Division name Honjo Clinic
Zip code
Address 1-29-1 Honjo Sumida-Ku
TEL 03-5608-7251
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Kobayashi
Organization Medical Co.LTA Honjo Clinic
Division name Honjo Clinic
Zip code
Address 1-29-1 Honjo Sumida-Ku
TEL 03-5608-7276
Homepage URL
Email

Sponsor
Institute APDD
Institute
Department

Funding Source
Organization APDD
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

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
2009 Year 06 Month 21 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 Completed
Date of protocol fixation
2009 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2009 Year 08 Month 01 Day
Date of closure to data entry
2009 Year 08 Month 01 Day
Date trial data considered complete
2009 Year 10 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 16 Day
Last modified on
2009 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002535

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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