UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010378 |
|---|---|
| Receipt number | R000012147 |
| Scientific Title | prevalence of cough in a cedar pollen season |
| Date of disclosure of the study information | 2013/04/02 |
| Last modified on | 2014/01/29 14:08:59 |
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Basic information
Public title
prevalence of cough in a cedar pollen season
Acronym
Cedar pollinosis and cough
Scientific Title
prevalence of cough in a cedar pollen season
Scientific Title:Acronym
Cedar pollinosis and cough
Region
| Japan |
Condition
Condition
pollinosis
Classification by specialty
| Clinical immunology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal prevalence of cough and factors which induce cough in a pollen season
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prevalence of cough in a pollen season
Key secondary outcomes
efficacy of anti-allergic drug or long acting-beta-stimulant for cough
Base
Study type
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
efficacy of anti-allergic drugs for cough
Interventions/Control_2
efficacy of tulobuterol tape for cough
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who are diagnosed as pollinosis
Key exclusion criteria
not applicable
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Kamijo |
Organization
Saitama Medical University
Division name
Otorhinolaryngology, Allergy Center
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1253
atkamijo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Kamijo |
Organization
Saitama Medical University
Division name
Otorhinolaryngology
Zip code
Address
38 Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1253
Homepage URL
atkamijo@saitama-med.ac.jp
Sponsor or person
Institute
Dept Otorhinolaryngology, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Dept. Otolaryngology, Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 04 | Month | 02 | 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 | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 01 | Day |
Last modified on
| 2014 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012147
