UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009840 |
|---|---|
| Receipt number | R000011530 |
| Scientific Title | The effect of early intervention for the patients with Japanese cedar pollinosis in children by Pranlukast dry syrup in the OHIO Chamber |
| Date of disclosure of the study information | 2013/01/26 |
| Last modified on | 2013/04/26 19:04:16 |
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Basic information
Public title
The effect of early intervention for the patients with Japanese cedar pollinosis in children by Pranlukast dry syrup in the OHIO Chamber
Acronym
TOPIC-J STUDY 3(Trial of OHIO Chamber Pranlukast inhibitory effect for cedar exposure)
Scientific Title
The effect of early intervention for the patients with Japanese cedar pollinosis in children by Pranlukast dry syrup in the OHIO Chamber
Scientific Title:Acronym
TOPIC-J STUDY 3(Trial of OHIO Chamber Pranlukast inhibitory effect for cedar exposure)
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis in children
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Administered 2 months, Pranlukast dry syrup or placebo in children with Japanese cedar pollinosis,just before the cedar pollen dispersal and nasal symptoms induced by OHIO Chmaber to determine the effectiveness of Pranlukast dry syrup in early intervention of cedar pollinosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nasal symptoms score
Key secondary outcomes
1)No of sneezing
2)Nasal secretion volume
3)Occurrence time of the first nasal symptoms
4)Consumption of rescue medicine
5)Eosinophil cationic protein
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pranlukast dry syrup are orally administered to 15 subjects at twice daily two months.
Japanese cedar pollen exposure mid-Feb. in OHIO Chamber.
Interventions/Control_2
Placebo dry syrup are orally administered to 15 subjects at twice daily two months.
Japanese cedar pollen exposure mid-Feb. in OHIO Chamber.
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
| 10 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Multiple antigen simultaneous test score against Japanese cedar pollen over class 2 in the past.
2)Have experience with cedar pollen exposure in OHIO Chamber in the past,patients with nasal symptoms with nasal congestion.
3)Patients who were judged to be suitable for patients enrollment by doctor in screening visit or medical examination results.
4)Written informed consent is required.
Key exclusion criteria
1)Some patients with mucosal lesion of the nose and eyes.
2)Patients who received steroid injections within 6 months.
3)Subjects with deformity of the nose polyp.
4)Subjects with systemic diseases(asthma or tuberculosis).
5)Patients with past history of anaphylaxis.
6)Patients who have the hypersensitivity to study drug.
7)Patients who have received immunotherapy.
8)Patients who were judged to be unsuitable for patients enrollment by doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimihiro Okubo |
Organization
Nippon Medical School
Division name
Department of Otorhinolaryngology and Head/neck Surgery
Zip code
Address
1-1-5 Sendagi,Bunkyo-ku,Tokyo 113-8603,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoko Shimizu |
Organization
Tokyo Reserch Center of Clinical Pharmacology co.,ltd.
Division name
CRC Section ,Clinical Trial Operations Support Dept.
Zip code
Address
TEL
Homepage URL
s-shimizu@trcp.co.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan Allergy Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
医療法人社団 信濃会 左門町クリニック
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 26 | 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
| 2013 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 04 | Month | 10 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 22 | Day |
Last modified on
| 2013 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011530
