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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005567
Receipt No. R000006592
Scientific Title Randomizing comparison concerning oral antimicrobial agent to otitis treatment in infant rapid character
Date of disclosure of the study information 2011/05/10
Last modified on 2018/05/14

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Basic information
Public title Randomizing comparison concerning oral antimicrobial agent to otitis treatment in infant rapid character
Acronym Randomizing comparison concerning oral antimicrobial agent to otitis treatment in infant rapid character
Scientific Title Randomizing comparison concerning oral antimicrobial agent to otitis treatment in infant rapid character
Scientific Title:Acronym Randomizing comparison concerning oral antimicrobial agent to otitis treatment in infant rapid character
Region
Japan

Condition
Condition Otitis media
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and side effect of the treatment for otitis media.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy, side effect
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 CDTR-PI
Interventions/Control_2 CVA/AMPC
Interventions/Control_3 AMPC
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
0 years-old <
Age-upper limit
15 years-old >
Gender Male and Female
Key inclusion criteria Infant patients with otitis media (0 - 15 years old)
Key exclusion criteria The patients with allergy against beta-lactam antibiotics
Target sample size 210

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Yamashita
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Otolaryngology
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL 0836-22-2281
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuma Sugahara
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Otolaryngology
Zip code
Address
TEL
Homepage URL
Email kazuma@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School of Medicine Department of Otolaryngology
Institute
Department

Funding Source
Organization Yamaguchi University Graduate School of Medicine Department of Otolaryngology
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
2011 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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 01 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 05 Month 07 Day
Last modified on
2018 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006592

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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