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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004232
Receipt No. R000005088
Scientific Title Preventing postoperative pain: Effect of Neurokinin-1 receptor antagonist
Date of disclosure of the study information 2010/09/18
Last modified on 2010/09/18

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Basic information
Public title Preventing postoperative pain: Effect of Neurokinin-1 receptor antagonist
Acronym Preventing postoperative pain: Effect of Neurokinin-1 receptor antagonist
Scientific Title Preventing postoperative pain: Effect of Neurokinin-1 receptor antagonist
Scientific Title:Acronym Preventing postoperative pain: Effect of Neurokinin-1 receptor antagonist
Region
Japan

Condition
Condition postoperative pain
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluating the efficacy and tolerability of aprepitant for theprevention of the postoperative pain.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes postoperative pain and morphine consumption
Key secondary outcomes frequency of the PONV and pruritus

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
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 abdominal surgery of gynaecology are randomly assigned aprepitant group to Control group. On the day of surgery, aprepitant group takes orally Aprepitant (125mg) at 2 hours before induction of anesthesia.
Interventions/Control_2 Control group akes orally placebo (lactose powder capsule; 40 mg) at 2 hours 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
65 years-old >
Gender Male and Female
Key inclusion criteria Patients are 20-65 years old who met the criteria of the American Society of Anesthesiologists physical status of 1-2 and undergo abdominal surgery. Having written informed consent.
Key exclusion criteria Patiens are excluded the criteria of the American Society of Anesthesiologists physical status of over 3 and have the history of hypersensitivity for aprepitant.
Target sample size 95

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kawano
Organization Kochi Medical School Hospital
Division name Anesthesiology
Zip code
Address Kohasu, Oko, Nankoku City, Kochi 783-8505, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kochi Medical School Hospital
Division name Anesthesiology
Zip code
Address Kohasu, Oko, Nankoku City, Kochi 783-8505, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Anesthesiology, Kochi Medical School 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
2010 Year 09 Month 18 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 Preinitiation
Date of protocol fixation
2010 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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
2010 Year 09 Month 18 Day
Last modified on
2010 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005088

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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