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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007613
Receipt No. R000008789
Scientific Title Preventing postoperative nausea and vomiting: Effect of Neurokinin-1 receptor antagonist(Fosaprepitant)
Date of disclosure of the study information 2012/03/31
Last modified on 2015/03/20

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Basic information
Public title Preventing postoperative nausea and vomiting: Effect of Neurokinin-1 receptor antagonist(Fosaprepitant)
Acronym Preventing postoperative nausea and vomiting: Effect of Neurokinin-1 receptor antagonist
Scientific Title Preventing postoperative nausea and vomiting: Effect of Neurokinin-1 receptor antagonist(Fosaprepitant)
Scientific Title:Acronym Preventing postoperative nausea and vomiting: Effect of Neurokinin-1 receptor antagonist
Region
Japan

Condition
Condition postoperative nausea and vomiting
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluating the efficacy and tolerability of the nurokinin-1 receptor antagonists(fosaprepitant) for theprevention of the postoperative nausea and vomitting (PONV).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes frequency of the PONV
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients received general anesthesia for abdominal operation of gynecology assign Fosaprepitant group to Control group (ONS)in a randmized. On the day of surgery,Fosaprepitant group takes Fosaprepitant 150mg:iv 1 hours before anticipated induction of anesthesia.
Interventions/Control_2 Control group does not intervene on medicine.
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
70 years-old >=
Gender Female
Key inclusion criteria Eligible patients are between 20-70 years old who met the criteria of the American Society of Anesthesiologists(ASA) physical status of 1-3,and are scheduled for abdominal surgery of gynecology requiring an overnight hospital stay.
Key exclusion criteria Patiens are excluded the criteria of the American Society of Anesthesiologists(ASA) physical status of over 3 neurotic disease,kidney disorder,hepatic disorder and taked antiemetic drugs.Further,excluded contraindication of Aprepitant(an anamnesis of hypersensitivity and taked Pimozide).
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Tsutsumi
Organization Tokushima University Hospital
Division name Anesthesiology
Zip code
Address Kuramoto 3-18-15,Tokushima 770-8503,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokushima University Hospital
Division name Anesthesiology
Zip code
Address
TEL 088-633-7181
Homepage URL
Email

Sponsor
Institute Department of Anesthesiology,Tokushima University Hospital
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 03 Month 31 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
2012 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 05 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 03 Month 30 Day
Last modified on
2015 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008789

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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