UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004167 |
|---|---|
| Receipt number | R000005001 |
| Scientific Title | Efficacy of aprepitant on postoperative nausea and vomiting: Assesement with patient-controlled prevention of nause and vomiting (PCPNV). |
| Date of disclosure of the study information | 2010/09/07 |
| Last modified on | 2013/03/21 09:57:51 |
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Basic information
Public title
Efficacy of aprepitant on postoperative nausea and vomiting: Assesement with patient-controlled prevention of nause and vomiting (PCPNV).
Acronym
Aprepitant inhibits PONV
Scientific Title
Efficacy of aprepitant on postoperative nausea and vomiting: Assesement with patient-controlled prevention of nause and vomiting (PCPNV).
Scientific Title:Acronym
Aprepitant inhibits PONV
Region
| Japan |
Condition
Condition
Patients undergoing dento-oral surgery
Classification by specialty
| Anesthesiology | Operative medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of NK-1 receptor antagonist on PONV
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Consumption of postoperative anti-emetic agent
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aprepitant 125 mg was preoperatively administered in 20 patients undergoing oro-dental-surgeries and postoperative neusea and vomiting is evaluated.
Interventions/Control_2
Metoclopramide 10 mg was administered just before completion fo surgery in 20 patients undergoing oro-dental-surgeries and postoperative neusea a vomiting is evaluated. Preoperative administration of metoclopramide
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients for surgical correction of bite
Key exclusion criteria
Patients with pregnancy, having vomiting with 24 h before surgery in any etiology, allergy to any medications to be used prtioperatively, hepatic and renal disfunction.
Patients taking medications known to induce or inhibit cytochrome P-450 3A4.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Masaki |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Dento-oral Anesthesiology
Zip code
Address
4-1 Seiryou-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8401
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Syomu |
Organization
Tohoku University Graduate School of Dentistry
Division name
Syomu
Zip code
Address
TEL
Homepage URL
den-syomu@bereau.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Dentistry
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
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 | 07 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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 | 07 | Day |
Last modified on
| 2013 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005001
