UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015687 |
|---|---|
| Receipt number | R000018235 |
| Scientific Title | The intractaneous examination with a candidate puroduct for a standerd of house dust mite allergen extract |
| Date of disclosure of the study information | 2014/11/14 |
| Last modified on | 2014/11/14 07:56:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The intractaneous examination with a candidate puroduct for a standerd of house dust mite allergen extract
Acronym
The intractaneous examination with a candidate puroduct for a standerd of house dust mite allergen extract
Scientific Title
The intractaneous examination with a candidate puroduct for a standerd of house dust mite allergen extract
Scientific Title:Acronym
The intractaneous examination with a candidate puroduct for a standerd of house dust mite allergen extract
Region
| Japan |
Condition
Condition
House dust mite allergy
Classification by specialty
| Pneumology | Clinical immunology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the limes of skin test with a candedate product for a atanderd of house dust mite allergen extract
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the limes of skin test with a candedate product for a atanderd of house dust mite allergen extract
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Standardized Mite Extracts, Mixed mite(ALK- Abelló)
Interventions/Control_2
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
Positive specific IgE to house dust mite antigen(ImmunoCAP>=class2)
Key exclusion criteria
1)Dermatitis in a forearm which influence the reaction of the examination
2)Using drugs which influence the reaction of the examination
3)Pregnant women and those at risk of pregnancy
4)Expeirnce of immunotherapy for house dust mite
5)Severe athma
6)Irritation for adrenalin
7)Diseases of heart, liver, kidny, blood and infection which influence the reaction of the examination
8)The patients who the doctor judged inaproppriate for the study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Okamoto |
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
yoakamoto@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Syuji Yonekura |
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
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding 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
| 2014 | Year | 11 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 14 | Day |
Last modified on
| 2014 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018235
