UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032661 |
|---|---|
| Receipt number | R000037243 |
| Scientific Title | The effect of desloratadine on the urticariaresponse to the thermal stimuli. |
| Date of disclosure of the study information | 2018/05/21 |
| Last modified on | 2018/05/21 15:12:09 |
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Basic information
Public title
The effect of desloratadine on the urticariaresponse to the thermal stimuli.
Acronym
The effect of desloratadine on the urticariaresponse to the thermal stimuli.
Scientific Title
The effect of desloratadine on the urticariaresponse to the thermal stimuli.
Scientific Title:Acronym
The effect of desloratadine on the urticariaresponse to the thermal stimuli.
Region
| Japan |
Condition
Condition
urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of desloratadine on the urticaria response to the thermal stimuli
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The change in the critical temperature thresholds from baseline to week 8 of the treatment period
Key secondary outcomes
The change in UAS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Desloratadine for 8 weeks
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
| 12 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Age: 12-79 yrs
2)Positive results for Temp Test
Key exclusion criteria
1) Systemic treatment with corticosteroid and/or immunosuppressants
2) Liver and/or renal dysfunction(AST/ALT>100IU/ml, serum creatinine>1.5 mg/dl)
3) Pregnancy and brestfeeding
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoko Inomata |
Organization
Yokohama City University
Division name
Dermatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2675
ninomata@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Amiko Hakuta |
Organization
Yokohama City University
Division name
Dermatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2675
Homepage URL
ninomata@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 05 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | 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
| 2018 | Year | 05 | Month | 21 | Day |
Last modified on
| 2018 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037243
