UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000583 |
|---|---|
| Receipt number | 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 21:13:09 |
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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
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
Sponsor or person
Institute
Group study of Early Intervention of Pollinosis with Pranlukast
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000706
