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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030006
Receipt No. R000034203
Scientific Title pharmacokinetics and pharmacodynamics study of intraveneous acetaminophen
Date of disclosure of the study information 2017/11/20
Last modified on 2017/11/14

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Basic information
Public title pharmacokinetics and pharmacodynamics study of intraveneous acetaminophen
Acronym pharmacokinetics and pharmacodynamics study of intraveneous acetaminophen
Scientific Title pharmacokinetics and pharmacodynamics study of intraveneous acetaminophen
Scientific Title:Acronym pharmacokinetics and pharmacodynamics study of intraveneous acetaminophen
Region
Japan

Condition
Condition Patients who undergo head neck and oral surgery without nerve block or epidural anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate impact of differences in the administration rate of acetaminophen intraveneous drug and examine the relationship between pharmacokinetics and pharmacodynamics
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Blood concentration of acetaminophen
Key secondary outcomes VRS VAS NRS

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ASA 1 and 2
Adult patient with good condition
Key exclusion criteria 1.History of allergy to acetaminophen
2.History of aspirin asthma
3.Oral use of carbamazepine/phenobarbital/phenytoin/primidone/rifampicin
4.Psychoneurotic disorders
5.Psychiatric pharmacotherapy
6.Liver or advanced renal dysfunction
7.Alcohol drinkers and adddiction patient
8.Pregnant woman/breast-feeding
9.Those who were considered inadequate
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoko Suzuki
Organization Tohoku University
Division name Department of Anesthesiology and Perioperative Medicine
Zip code
Address 1-1 seiryoumachi aobaku sendai miyagi
TEL 0227177321
Email suzutomo@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Suzuki
Organization Tohoku University
Division name Department of Anesthesiology and Perioperative Medicine
Zip code
Address 1-1 seiryoumachi aobaku sendai miyagi
TEL 0227177321
Homepage URL
Email suzutomo@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
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
2017 Year 11 Month 20 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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observe intravenous acetaminophen blood concentration and analgesic effect after acetaminophen infusion

Management information
Registered date
2017 Year 11 Month 16 Day
Last modified on
2017 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034203

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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