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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007592
Receipt No. R000008965
Scientific Title Comparison of clinical efficacy between 3day combined clavulanate amoxicillin preparation treatment and 10day amoxicillin treatment in children with pharyngolaryngitis
Date of disclosure of the study information 2012/03/28
Last modified on 2012/03/28

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Basic information
Public title Comparison of clinical efficacy between 3day combined clavulanate amoxicillin preparation treatment and 10day amoxicillin treatment in children with pharyngolaryngitis
Acronym Comparison of clinical efficacy between 3day combined clavulanate amoxicillin preparation treatment and 10day amoxicillin treatment in children with pharyngolaryngitis
Scientific Title Comparison of clinical efficacy between 3day combined clavulanate amoxicillin preparation treatment and 10day amoxicillin treatment in children with pharyngolaryngitis
Scientific Title:Acronym Comparison of clinical efficacy between 3day combined clavulanate amoxicillin preparation treatment and 10day amoxicillin treatment in children with pharyngolaryngitis
Region
Japan

Condition
Condition pharyngolaryngitis tonsillitis
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficacy of 3-day treatment with a CVA/AMPC and 10-day treatment with AMPC against pediatric pharyngolaryngitis and tonsillitis caused by GAS was compared.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes clinical efficacy
Key secondary outcomes safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 CVA/AMPC
Interventions/Control_2 AMPC
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
0 years-old <=
Age-upper limit
15 years-old >
Gender Male and Female
Key inclusion criteria The study included children with pharyngolaryngitis or tonsillitis, aged less than 15 years, who tested positive on the instantaneous Group A Streptococcus infection diagnosis kit between November 2009 and May 2011.
Key exclusion criteria Penicillin allergy
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naruhiko Ishiwada
Organization Chiba University
Division name Division of Infectious diseases
Zip code
Address Inohana Chuoku Chibashi Chiba
TEL 043-222-7171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naruhiko Ishiwada
Organization Chiba University
Division name Division of Infectious Diseases
Zip code
Address Inohana Chuoku Chibashi Chiba
TEL 043-222-7171
Homepage URL
Email

Sponsor
Institute Chiba University
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
2012 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results Partially 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
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2012 Year 01 Month 01 Day
Date of closure to data entry
2012 Year 02 Month 01 Day
Date trial data considered complete
2012 Year 02 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 28 Day
Last modified on
2012 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008965

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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