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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013459
Receipt No. R000015716
Scientific Title Pepsinogen measurement of middle ear effusion in for treatment-resistant otitis media of infants
Date of disclosure of the study information 2014/04/01
Last modified on 2015/09/19

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Basic information
Public title Pepsinogen measurement of middle ear effusion in for treatment-resistant otitis media of infants
Acronym Pepsinogen measurement of middle ear effusion
Scientific Title Pepsinogen measurement of middle ear effusion in for treatment-resistant otitis media of infants
Scientific Title:Acronym Pepsinogen measurement of middle ear effusion
Region
Japan

Condition
Condition Treatment-resistant otitis media of infants
Classification by specialty
Oto-rhino-laryngology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Since the gastric fluid will flow back esophagus, pharynx to the stomach and to confirm that you have reached the middle ear cavity and further.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Determine gastroesophageal reflux whether related to the background of treatment-resistant otitis media in children pepsinogen 1 amount of accumulated fluid in the interview, medical history, and treatment history, from the reservoir fluid pH.
Key secondary outcomes

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 PPI
Interventions/Control_2
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 Treatment-resistant otitis media of infants
Key exclusion criteria None
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hijiriko Iwasaki
Organization The Jikei University School of Medicine
Division name Otorhinolaryngology
Zip code
Address 3-25-8, Nishi-Shinbashi, Minatoku, Tokyo, Japan
TEL 03-3433-1111
Email hijiriko@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hijiriko Iwasaki
Organization The Jikei University School of Medicine
Division name Otorhinolaryngology
Zip code
Address 3-25-8, Nishi-Shinbashi, Minatoku, Tokyo, Japan
TEL 03-3433-1111
Homepage URL
Email hijiriko@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization The Jikei University School of Medicine
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
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
2014 Year 04 Month 01 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
2014 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 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
2014 Year 03 Month 18 Day
Last modified on
2015 Year 09 Month 19 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015716

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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