UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013418 |
|---|---|
| Receipt number | 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 16:42:55 |
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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
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
masui@fmu.ac.jp
Sponsor or person
Institute
Anesthesiology, Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015671
