UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012999
Receipt No. R000015175
Scientific Title Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting-orthopedic surgery-
Date of disclosure of the study information 2014/01/31
Last modified on 2015/08/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting-orthopedic surgery-
Acronym Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting-orthopedic surgery-
Scientific Title Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting-orthopedic surgery-
Scientific Title:Acronym Fosaprepitant versus Ondansetron for prevention of postoperative nausea and vomiting-orthopedic surgery-
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 nausea and vimiting
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 Fosaprepitant group takes fosaprepitant 150mg div before induction of anesthesia.
Interventions/Control_2 Ondansetron group takes ondansetron 4mg div before induction of 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 American Society of Anesthesiologists(ASA) physical status 1-2 , who are recieved limb surgery(total knee replacement, total hip replacement)
Key exclusion criteria Patients are excluded the criteria of the ASA Physical Status of over 3 and taked other antiemetics.
Further,excluded contraindication of fosaprepitant and ondansetron.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eisuke Hamaguchi
Organization Tokushima University Hospital
Division name Anesthesiology
Zip code
Address Kuramoto 3-18-15, Tokushima 770-8503, Japan
TEL 088-633-7181
Email hamaguchi@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiusuke Hamaguchi
Organization Tokushima University Hospital
Division name Anesthesiology
Zip code
Address Kuramoto 3-18-15, Tokushima 770-8503, Japan
TEL 088-633-7181
Homepage URL
Email hamaguchi@tokushima-u.ac.jp

Sponsor
Institute Depertment of Anesthesiology, Tokushima Nniversity Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
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 01 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 07 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 31 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
2014 Year 01 Month 28 Day
Last modified on
2015 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015175

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.