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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007181
Receipt No. R000008457
Scientific Title The effect of early intervention for the patients with Japanese cedar pollinosis by Pranlukast Hydrate in the OHIO Chamber.
Date of disclosure of the study information 2012/01/31
Last modified on 2012/03/15

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Basic information
Public title The effect of early intervention for the patients with Japanese cedar pollinosis by Pranlukast Hydrate in the OHIO Chamber.
Acronym TOPIC-J STUDY 2(Trial of OHIO Chamber Pranlukast inhibitory effect for cedar exposure)
Scientific Title The effect of early intervention for the patients with Japanese cedar pollinosis by Pranlukast Hydrate in the OHIO Chamber.
Scientific Title:Acronym TOPIC-J STUDY 2(Trial of OHIO Chamber Pranlukast inhibitory effect for cedar exposure)
Region
Japan

Condition
Condition Japanese cedar pollinosis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Administered 1 month from Feb. 29 through Feb. 01, Pranlukast or placebo in patients with Japanese cedar pollinosis, just before the cedar pollen dispersal (mid-Feb.) and nasal symptoms induced by OHIO Chamber to determine the effectiveness of Pranlukast in early intervention of cedar pollinosis.
Basic objectives2 Safety,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 symptom

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 Hydrate capsules are orally administered to 15 subjects at twice daily one month from Feb. 29 through Feb. 01.
Japanese cedar pollen exposure mid-Feb. in OHIO Chamber.
Interventions/Control_2 Placebo capsules are orally administered to 15 subjects at twice daily one month from Feb. 29 through Feb. 01.
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1) CAP-RAST score against Japanese cedar pollen over class 2 in the past.
2) Have experience with cedar pollen exposure in the 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 or a 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) Pregnancy, breast-feeding woman, potencial pregnancy, patients who wish to become pregnant during this study.
9) 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 Kiyochika Suematsu
Organization Medical Corporation Shinanokai, Samoncho Clinic
Division name Pharmaceutical Dept.,
Zip code
Address Yotsuya Medical Bldg., 20, Samon-cho, Shinjuku-ku, Tokyo, 160-0017, Japan
TEL 03-5366-3641
Homepage URL
Email ki-suematsu@samoncho-clinic.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization Public Health Research 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 Medical Corporation Shinanokai, Samoncho Clinic

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 31 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 01 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 31 Day
Last modified on
2012 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008457

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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