UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029653 |
|---|---|
| Receipt number | R000033885 |
| Scientific Title | Comparison of an effect of the secondgeneration antihistamines with deiffenrent configuration for Japanese cedar pollinosis (the randomized, placebo controled, double blind study using an environmental challrenge chamber) |
| Date of disclosure of the study information | 2017/10/22 |
| Last modified on | 2019/02/19 06:12:07 |
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Basic information
Public title
Comparison of an effect of the secondgeneration antihistamines with deiffenrent configuration for Japanese cedar pollinosis (the randomized, placebo controled, double blind study using an environmental challrenge chamber)
Acronym
Comparison of an effect of the antihistaminesfor Japanese cedar pollinosis
Scientific Title
Comparison of an effect of the secondgeneration antihistamines with deiffenrent configuration for Japanese cedar pollinosis (the randomized, placebo controled, double blind study using an environmental challrenge chamber)
Scientific Title:Acronym
Comparison of an effect of the antihistaminesfor Japanese cedar pollinosis
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the difference of an effect of the second generation antihistamines with different configuration (desloratadine and levocetirizine) for Japanese cedar pollinosis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total nasal symptom score when Japanese cedar pollen exposition was performed for 3 hours in the environmental challrenge chamber
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The group which took desloratadine (5mg)on the day before of pollen exposition
Interventions/Control_2
The group which took levocetirizine (5mg) on the day before of pollen exposition
Interventions/Control_3
The group which took placebo on the day before of pollen exposition
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)Patients who have medical history of cedar pollinosis for more than 2 years.
2)Patients who do not have nasal symtoms induced by any allergen and requier any drug treatment out of Japanese cedar pollen scattering season.
3)Positive specific IgE to cedar pollen allergen(>=class2)
4)Patients who develop more tha derate symptoms by a pollen exposure for 3 hours.
Key exclusion criteria
1) Drug allergy for antihistaines including intervention medicines
2) Patinets with allergic rhinitis to require treatment in non-scattering period of Japanese cedar pollen
3) Patients with nasal disease that affects the evaluation of the study
4) Severe respiratory disease, heart disease, liver disease, kidney disease, diabetes, autoimmune disease
5) Pregnant women and those at risk of pregnancy
6) Women who are planning pregnancy
7) Lactating woman
8) Patients treated with anti-allergic drugs within 2 week of screening
9) The patients who the doctor judged inappropriate for the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Okamoto Yoshitaka |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-222-7171
yokamoto@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yonekura Syuji |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-222-7171
Homepage URL
syonekura@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Otorhinolaryngology in Ciba University Graduate School
Institute
Department
Personal name
Funding Source
Organization
KYORIN Holdings, Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 10 | Month | 22 | 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
50 cases participaterd in the trial. In comparison with a placebo, total nasal symptom score, a primaly end point, were lowere in desloratadine and levocetirizine groups. However, the statistical significant difference between desloratadine and levocetiridize was not clear.
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
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 23 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 22 | Day |
Last modified on
| 2019 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033885
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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