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Recruitment status
Unique ID issued by UMIN UMIN000000583
Receipt No. R000000706
Scientific Title Clinical study of pranlukast as early seasonal treatment for Japanese cedar pollinosis
Date of disclosure of the study information 2007/02/05
Last modified on 2008/02/03

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Basic information
Public title Clinical study of pranlukast as early seasonal treatment for Japanese cedar pollinosis
Acronym Clinical study of pranlukast as early seasonal treatment for Japanese cedar pollinosis(EIPP:Early Intervention of Pollinosis with Pranlukast)
Scientific Title Clinical study of pranlukast as early seasonal treatment for Japanese cedar pollinosis
Scientific Title:Acronym Clinical study of pranlukast as early seasonal treatment for Japanese cedar pollinosis(EIPP:Early Intervention of Pollinosis with Pranlukast)
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy and safety of pranlukast as early seasonal treatment for Japanese cedar pollinosis by multi-center,prpspective,randomized,placebo-controlled trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Symptom-medication score (symptomscore+medication score)
Key secondary outcomes Symptom score (stuffy nose,runny nose, sneezing,eye itchiness and tearing), medication score and QOL Questionaire score(JRQLQ No1)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Medical treatment is started before the beginning of pollen scattering. Two pranlukast capsules twice a day, after breakfast and dinner (total 4 pranlukast capsules/day) are orally administered from 3rd or 4th Feb. to 31st Mar. or 1st Apr. If necessary, drugs at the same time are used according to"Practical Guideline for the Management of Allergic Rhinitis in Japan" from 17th or 18th Feb. to 31st Mar. or 1st Apr.
Interventions/Control_2 Medical treatment is started before the beginning of pollen scattering. Two placebo capsules twice a day, after breakfast and dinner (total 4 placebo capsules /day) are orally administered from 3rd or 4th Feb. to 3rd or 4th Mar. After that, Two pranlukast capsules twice a day, after breakfast and dinner (total 4 pranlukast capsules/day) are orally administered from 3rd or 4th Mar. to 31st Mar. or 1st Apr. If necessary, drugs at the same time are used according to "Practical Guideline for the Management of Allergic Rhinitis in Japan" from 17th or 18th Feb. to 31st Mar. or 1st Apr.
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) a history of Japanese cedar pollinosis last year
2) differential diagnosis by rhinoscopy test
3) positive allergy test to Japanese cedar pollen
4) mild nasal symptoms, especially stuffy nose , with pollinosis
Key exclusion criteria 1) any other disease, nasal polyp, acute/chronic rhinitis, sinusitis et al
2) use of any anti-histamine drugs, anti-allergy drugs, nasal steroid drugs et al at the beginning of the study
3) buildup phase of immunotherapy to Japanese cedar pollen
4) pregnancy, potential pregnancy, or lactation
5) the others, inappropriate to this study by the judgment of doctor
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Okamoto
Organization Chiba University Graduate School of Medicine
Division name Department of Otorhinolaryngology
Zip code
Address 1-8-1 Inohana,Chuo-ku Chiba 260-0856
TEL 043-222-7171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toru Okawa
Organization Chiba University Graduate School of Medicine
Division name Department of Otorhinolaryngology
Zip code
Address 1-8-1 Inohana,Chuo-ku Chiba 260-0856
TEL 043-222-7171
Homepage URL
Email

Sponsor
Institute Group study of Early Intervention of Pollinosis with Pranlukast
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

Other administrative information
Date of disclosure of the study information
2007 Year 02 Month 05 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
Date of protocol fixation
2006 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
2007 Year 04 Month 01 Day
Date of closure to data entry
2007 Year 05 Month 01 Day
Date trial data considered complete
2007 Year 05 Month 01 Day
Date analysis concluded
2007 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 01 Month 25 Day
Last modified on
2008 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000706

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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