UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009193 |
|---|---|
| Receipt number | R000010685 |
| Scientific Title | Evaluation of a rapid immunochromatographic test for detection of pneumococcal antigen in acute otitis media |
| Date of disclosure of the study information | 2012/10/27 |
| Last modified on | 2013/11/26 09:28:32 |
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Basic information
Public title
Evaluation of a rapid immunochromatographic test for detection of pneumococcal antigen in acute otitis media
Acronym
Evaluation of a rapid immunochromatographic test for detection of pneumococcal antigen in acute otitis media
Scientific Title
Evaluation of a rapid immunochromatographic test for detection of pneumococcal antigen in acute otitis media
Scientific Title:Acronym
Evaluation of a rapid immunochromatographic test for detection of pneumococcal antigen in acute otitis media
Region
| Japan |
Condition
Condition
acute otitis media
Classification by specialty
| Oto-rhino-laryngology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the rapid immunochromatographic test for detection of pneumococcal antigen in the treatment of acute otitis media.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Evaluation of a rapid immunochromatographic test for detection of pneumococcal antigen by investigators
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Children below 15 years of ages with acute otitis media.
2.Diagnosed as moderate or severe in the clinical severity by clinical practice guidelines for the diagnosis and management of acute otitis media (AOM) in children in Japan(2009).
Key exclusion criteria
none
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Muneki Hotomi |
Organization
Wakayama Medical University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
811-1 Kimiidera, Wakayama-shi, Wakayama 641-8509, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Wakayama-Okayama Otolaryngology Pharma
Division name
secretariat
Zip code
Address
TEL
086-805-8722
Homepage URL
woop@calo.co.jp
Sponsor or person
Institute
Wakayama-Okayama Otolaryngology Pharma
Institute
Department
Personal name
Funding Source
Organization
Wakayama-Okayama Otolaryngology Pharma
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
| 2012 | Year | 10 | Month | 27 | 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
| 2012 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the rapid immunochromatographic test for detection of pneumococcal antigen in the treatment of acute otitis media.
Management information
Registered date
| 2012 | Year | 10 | Month | 26 | Day |
Last modified on
| 2013 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010685
