UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030006 |
|---|---|
| Receipt number | R000034203 |
| Scientific Title | pharmacokinetics and pharmacodynamics study of intraveneous acetaminophen |
| Date of disclosure of the study information | 2017/11/20 |
| Last modified on | 2021/04/14 10:09:06 |
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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 | Tomoko |
| Middle name | |
| Last name | Suzuki |
Organization
Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
1-1 seiryoumachi aobaku sendai miyagi
TEL
0227177321
tomoko.suzuki.r2@dc.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Suzuki |
Organization
Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
1-1 seiryoumachi aobaku sendai miyagi
TEL
0227177321
Homepage URL
tomoko.suzuki.r2@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sendai Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University
Address
1-1 Seiryoumachi Aobaku Sendai Miyagi Japan
Tel
0227177321
tomoko.suzuki.r2@dc.tohoku.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
29-55 20-64
Org. issuing International ID_1
National Hospital Organization Sendai Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
仙台医療センター(宮城県)
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
51
Results
As a result of examining the results of NRS in 3 groups and postoperative analgesics and the characteristics of the blood concentration transition curve, when intravenous APAP 1000 mg is used intraoperatively and postoperatively, the analgesic effect was high with the administration method that combined rapid single administration and continuous administration.
Results date posted
| 2021 | Year | 04 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adult patients undergoing minor oral surgery under general anesthesia at Sendai Medical Center (American Society of Anesthesia Preoperative Status Classification ASA physical status I-II)
Participant flow
Tohoku University Ethics Committee and National Hospital Organization Sendai Medical Center Ethics Committee after approval, oral and written explanations with consent, the patient himself signed the consent form in writing.
Adverse events
no
Outcome measures
Use of NRS and postoperative analgesics up to 240 minutes after dosing and Cmax, tmax, AUC, effective blood concentration arrival time, effective blood concentration maintenance time according to the drawn plasma concentration transition curve.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 30 | Day |
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
| 2021 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034203
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| Research case data | |
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