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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018532
Receipt No. R000021445
Scientific Title Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting in oral and maxillofacial surgery
Date of disclosure of the study information 2015/10/10
Last modified on 2016/03/25

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Basic information
Public title Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting in oral and maxillofacial surgery
Acronym Fosaprepitant versus Ondansetron for prevention of PONV
Scientific Title Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting in oral and maxillofacial surgery
Scientific Title:Acronym Fosaprepitant versus Ondansetron for prevention of PONV
Region
Japan

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

Objectives
Narrative objectives1 We compare Fosaprepitant with Ondansetron for prevention of postoperative nausea and vomiting.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes frequency of the postoperative vomiting/nausea.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Fosaprepiitant group takes fosaprepitant 150mg div before induction os anesthesia.
Interventions/Control_2 Ondansetron group takes ondansetron 4mg div before induction os anesthesia.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Eligible patients meet the criteria of the ASA PS 1-3, who are received oral surgery.
Key exclusion criteria ASA PS over IV.
Take other antiemetics.
Containdication to fosaprepitant or ondansetron.
Target sample size 20

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 3-18-15 Kurtamoto Tokushima
TEL 088-633-7181
Email tsutsumi@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Tsutsumi
Organization Tokushima University Hospital
Division name Anesthesiology
Zip code
Address 3-18-15 Kurtamoto Tokushima
TEL 088-633-7181
Homepage URL
Email tsutsumi@tokushima-u.ac.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization Tokushima University Hospital
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
2015 Year 10 Month 10 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
2015 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 10 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
2015 Year 08 Month 03 Day
Last modified on
2016 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021445

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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