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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005243
Receipt No. R000005994
Scientific Title Establishment of safe and reliable sleep induction for children in urologic examination
Date of disclosure of the study information 2011/03/14
Last modified on 2013/04/19

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Basic information
Public title Establishment of safe and reliable sleep induction for children in urologic examination
Acronym Establishment of safe and reliable sleep induction for children in urologic examination
Scientific Title Establishment of safe and reliable sleep induction for children in urologic examination
Scientific Title:Acronym Establishment of safe and reliable sleep induction for children in urologic examination
Region
Japan

Condition
Condition Children who need sedation for urolgral examination
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Establishment of safe and reliable sleep induction for children
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of saccessful sleep induction
Key secondary outcomes Difference on side effect among the methods for sleep induction

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 GroupA:
administration of TRICLORYL Syrup(Triclofos Sodium)(80mg/kg) and ESCRE suppository (Choral hydrate)(50mg/kg)

Interventions/Control_2 GroupB:
ESCRE suppository (Choral hydrate)(50mg/kg)

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

Not applicable
Age-upper limit
4 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients less than 4 years old who undergo ezamination under sedation
2. Patients whose guardian(s) aguree to participate in this study
Key exclusion criteria 1.Patients who are judged improper to participate in this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimihiko Moriya
Organization Hokkaido University Hospital
Division name Department of Renul and Genitourinary surgery
Zip code
Address Kita 14, Nishi 5,Kita-ku Sapporo,Hokkaido,japan
TEL 011-706-5966
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kimihiko Moriya
Organization Hokkaido University Hospital
Division name Department of Renul and Genitourinary surgery
Zip code
Address Kita 14 ,Nishi 5,Kita-ku Sapporo,Hokkaido,japan
TEL 011-706-5966
Homepage URL
Email k-moriya@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Department of Renul and Genitourinary surgery Hokkaido University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 14 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
2011 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2012 Year 12 Month 28 Day
Date of closure to data entry
2012 Year 12 Month 28 Day
Date trial data considered complete
2012 Year 12 Month 28 Day
Date analysis concluded
2013 Year 03 Month 15 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 14 Day
Last modified on
2013 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005994

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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