UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013459 |
|---|---|
| Receipt number | 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 23:48:32 |
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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
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
hijiriko@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015716
