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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013908
Receipt No. R000015612
Scientific Title Safety of olanzapine for the prevention of postoperative nausea and vomiting
Date of disclosure of the study information 2014/05/12
Last modified on 2014/11/08

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Basic information
Public title Safety of olanzapine for the prevention of postoperative nausea and vomiting
Acronym Safety of olanzapine
Scientific Title Safety of olanzapine for the prevention of postoperative nausea and vomiting
Scientific Title:Acronym Safety of olanzapine
Region
Japan

Condition
Condition gynecological begnin diseases
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm safety of prophylactic use of olanzapine for the prevention of postoperative nausea and vomiting
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes extrapyramidal syndrom, excessive sedation, hyperglycemia, arrythmia
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 Prevention
Type of intervention
Medicine
Interventions/Control_1 olanzapine
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 Female
Key inclusion criteria Patients
1) who receive laparoscopic gynecological surgery for benign disease.
2) who are equal to or older than 20 years old.
3) with American Society of Anesthesiologists Physical Status 1 or 2
Key exclusion criteria Patients
1) who receive epidural anesthesia
2) who were contraindicated to any of the study drugs
3) who have diabetes
4) who take emetogenic or antiemetic drugs within the 24 hours before surgery,
5) who receive emergency surgery
6) who receive open surgery
7) who are pregnant or lactating
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Seki
Organization School of Medicine, Keio University
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi, Shinjukuku Tokyo, Japan
TEL 03-3353-1211
Email hshiroyukiseki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Seki
Organization School of Medicine, Keio University
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi Shinjukuku, Tokyo Japan
TEL 03-3353-1211
Homepage URL
Email hshiroyukiseki@gmail.com

Sponsor
Institute Department of Anesthesiology, School of Medicine, Keio University
Institute
Department

Funding Source
Organization Department of Anesthesiology, School of Medicine, Keio 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
2014 Year 05 Month 12 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 Completed
Date of protocol fixation
2014 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 14 Day
Last follow-up date
2014 Year 10 Month 01 Day
Date of closure to data entry
2014 Year 10 Month 01 Day
Date trial data considered complete
2014 Year 10 Month 01 Day
Date analysis concluded
2014 Year 10 Month 20 Day

Other
Other related information

Management information
Registered date
2014 Year 05 Month 08 Day
Last modified on
2014 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015612

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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