UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025608 |
|---|---|
| Receipt number | R000028748 |
| Scientific Title | A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection |
| Date of disclosure of the study information | 2017/01/11 |
| Last modified on | 2019/07/16 10:31:31 |
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Basic information
Public title
A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection
Acronym
A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection
Scientific Title
A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection
Scientific Title:Acronym
A prospective multicenter study of the efficacy of pranlukast hydrate for infant patients with acute wheezing illness caused by RS virus infection
Region
| Japan |
Condition
Condition
Repsratory Syncytial virus: RSV
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A study of the efficacy of pranlukast hydrate for infant patients with acute wheezing caused by RS virus infection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate whether internal use of pranlukast from an early stage after hospitalization contributes to the reduction of symptom within onset one month in children hospitalized with acute wheezing caused by RS virus infection.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In intervention group, PO 7mg/kg per day as pranlukast hydrate, in 2 divided doses for 28days in addition to supportive care as usual
Interventions/Control_2
In control group, supportive care as usual
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
| 1 | months-old | < |
Age-upper limit
| 24 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Children hospitalized with RSV bronchiolitis
Key exclusion criteria
Children with comorbidity
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Sato |
Organization
Nagoya University Hospital
Division name
Centor for Maternal-Neonatal Care
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-741-2111
yoshiaki@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Takeuchi |
Organization
Nagoya University Graduate School of Medicine
Division name
Pediatrics/Developmental pediatrics
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-741-2111
Homepage URL
suguru-t@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
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
Institutional Review Board of Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel
052-741-2111
ethics@med.nagoya-u.ac.jp
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
| 2017 | Year | 01 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 10 | Day |
Last modified on
| 2019 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028748
