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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009840
Receipt No. 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

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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
Email

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
Email s-shimizu@trcp.co.jp

Sponsor
Institute Nippon Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011530

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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