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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013418
Receipt No. R000015671
Scientific Title Pharmacokinetics and pharmacodynimics of intravenous acetaminophen in Japanese surgical patients
Date of disclosure of the study information 2014/03/14
Last modified on 2019/03/11

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Basic information
Public title Pharmacokinetics and pharmacodynimics of intravenous acetaminophen in Japanese surgical patients
Acronym Pharmacology of intravenous acetaminophen
Scientific Title Pharmacokinetics and pharmacodynimics of intravenous acetaminophen in Japanese surgical patients
Scientific Title:Acronym Pharmacology of intravenous acetaminophen
Region
Japan

Condition
Condition Patients who undergo surgeries under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To test the hypothesis that the effect of intravenous acetaminophen lasts longer when the drug is administered with longer duration than with shorter duration and to construct a population pharmacokinetic model of intravenous acetaminophen
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analgesics required postoperatively
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Control (no acetaminophen)
(Pharmacokinetic analysis will be performed with 3 groups below; no control group is required)
Interventions/Control_2 15 min of duration of administration of intravenous acetaminophen
Interventions/Control_3 60 min of duration of administration of intravenous acetaminophen
Interventions/Control_4 120 min of duration of administration of intravenous acetaminophen
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria ASA 1,2, and 3
Patients who undergo elective surgeries
Key exclusion criteria 1.Known allergy to acetaminophen
2.Psychoneurotic disorders
3.Psychiatric pharmacotherapy
4.Chronic use of ACET, NSAIDs or opioids
5.Women who were pregnant or breast-feeding
6.Anemia
7.Liver or advanced renal dysfunction
8.Those who were considered inadequate
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Murakawa
Organization Fukushima Medical University
Division name Anesthesiology
Zip code 9601295
Address 1 Hikarigaoka, Fukusima City, Fukushima
TEL 0245471342
Email masui@fmu.ac.jp

Public contact
Name of contact person
1st name Shinju
Middle name
Last name Obara
Organization Fukushima Medical University
Division name Anesthesiology
Zip code 9601295
Address 1 Hikarigaoka, Fukusima City, Fukushima
TEL 0245471342
Homepage URL
Email masui@fmu.ac.jp

Sponsor
Institute Anesthesiology, Fukushima Medical University
Institute
Department

Funding Source
Organization Anesthesiology, Fukushima Medical 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 Fukushima Medical University Ethics Committee
Address 1 Hikarigaoka, Fukushima City, Fukushima
Tel 0245471111
Email rs@fmu.ac.jp

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 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 60
Results Using 185 datapoints from 12 patients, the pharmacokinetics of i.v. acetaminophen were described by a two compartment model with weight as a covariate. The pharmacokinetic model of i.v. acetaminophen reported by Wurthwein et al.(Eur J Clin Pharmacol.2005;60:883) worked well.
Above pharmacokinetic analysis was published as a final result.
(J Anesth, DOI 10.1007/s00540_017_2358_7)

Results date posted
2019 Year 03 Month 11 Day
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
2014 Year 03 Month 13 Day
Date of IRB
2014 Year 03 Month 13 Day
Anticipated trial start date
2014 Year 03 Month 17 Day
Last follow-up date
2018 Year 12 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 14 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015671

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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