UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002084 |
|---|---|
| Receipt number | 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 09:55:55 |
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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
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
Sponsor or person
Institute
APDD
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002535
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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