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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007034
Receipt No. R000008074
Scientific Title Pharmakocinetics of landiolol in gynecologic patients
Date of disclosure of the study information 2012/01/10
Last modified on 2012/01/07

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Basic information
Public title Pharmakocinetics of landiolol in gynecologic patients
Acronym Pharmakocinetics of landiolol in gynecologic patients
Scientific Title Pharmakocinetics of landiolol in gynecologic patients
Scientific Title:Acronym Pharmakocinetics of landiolol in gynecologic patients
Region
Japan

Condition
Condition Surgical gynecologic disease
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Pharmacokinetics of landiolol
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma concentration of landiolol from the start of administration until 20 min after the end of administration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Landiolol was administered at target concentrations of 0.5 and 1.0 mcg/mL for each 30 min at each target concentration..
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Female
Key inclusion criteria Patients with body weight of less than 80 kg and ASA physical status 1 or 2
Key exclusion criteria Patients with arrhythmia, patinets medicated with alpha-methyldopa, clonidine or beta-blocker
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Kunisawa
Organization Asahikawa Medical University
Division name Anesthesiology and CCM
Zip code
Address 2-1-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Kunisawa
Organization Asahikawa Medical University
Division name Anesthesiology and CCM
Zip code
Address
TEL
Homepage URL
Email taka.kunisawa@nifty.ne.jp

Sponsor
Institute Department of Anesthesiology and CCM, Asahikawa Medical University
Institute
Department

Funding Source
Organization None
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
2012 Year 01 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The pharmacokinetics of landiolol is best described by a two-compartment model with lag time. There were no significant covariates (17th Japanese Society of Intravenous Anesthesia 2010).
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
2007 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2007 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 07 Day
Last modified on
2012 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008074

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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