UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020102 |
|---|---|
| Receipt number | R000023221 |
| Scientific Title | Evluation of clinical trial for the rapid diagnostic kit of norovirus |
| Date of disclosure of the study information | 2015/12/07 |
| Last modified on | 2015/12/22 12:25:15 |
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Basic information
Public title
Evluation of clinical trial for the rapid diagnostic kit of norovirus
Acronym
Clinical trial of the rapid diagnosis of norovirus
Scientific Title
Evluation of clinical trial for the rapid diagnostic kit of norovirus
Scientific Title:Acronym
Clinical trial of the rapid diagnosis of norovirus
Region
| Japan |
Condition
Condition
Norovirus
Classification by specialty
| Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the rapid diagnostic kit based on an immunochromatographic assay for the detection of norovirus in stool specimens.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity, specificity and concordance rate in comparison with the RT-PCR method
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient applicable to the following items
1)The patient who has one or more items of the following clinical condition
a. Diarrhea
b. Emesis
c. Stomachache
2)The patient considered that inspection by an norovirus rapid diagnostic kit is required
3) The patient who has agreed with the participation to this clinical trial
Key exclusion criteria
The patient applicable to the following items
1)The patient who has participated in other clinical trials
2)The patient judged to be unsuitable by the doctor
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Kimura |
Organization
EIKEN CHEMICAL Co., Ltd.
Division name
Biochemical Research Laboratory-I
Zip code
Address
143 Nogi, Nogi-machi, Shimotsuga-gun, Tochigi, 329-0114 Japan
TEL
0280-56-1221
Akira_Kimura@eiken.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Watanabe |
Organization
EIKEN CHEMICAL Co., Ltd.
Division name
Biochemical Research Laboratory-I
Zip code
Address
143 Nogi, Nogi-machi, Shimotsuga-gun, Tochigi, 329-0114 Japan
TEL
0208-57-0715
Homepage URL
Kazunori_Watanabe@eiken.co.jp
Sponsor or person
Institute
EIKEN CHEMICAL Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
EIKEN CHEMICAL Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
若葉こどもクリニック（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 07 | 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
As compared to RT-PCR, the sensitivity, secificity and concordance rate is 79.3% (169/213), 99.4%(357/359) and 92.0% (526/572), respectively.
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 | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 07 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 07 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 07 | Day |
Other
Other related information
After informed consent was obtained, fecal samples were collected from pediatric patients with sporadic gastroenteritis in Saitama Prefectures in Japan between January and September 2015. All of the fecal samples were assayed by real-time RT-PCR and rapid diagnostic kit for norovirus detection.
Management information
Registered date
| 2015 | Year | 12 | Month | 07 | Day |
Last modified on
| 2015 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023221
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
