UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013777 |
|---|---|
| Receipt number | R000015971 |
| Scientific Title | Study of medication timing of levocetirizine dihydrochloride in patients with recalcitrant chronic urticaria to anti-histamine drug |
| Date of disclosure of the study information | 2014/04/25 |
| Last modified on | 2016/04/21 21:40:15 |
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Basic information
Public title
Study of medication timing of levocetirizine dihydrochloride in patients with recalcitrant chronic urticaria to anti-histamine drug
Acronym
Study of medication timing of levocetirizine in patients with recalcitrant chronic urticaria
Scientific Title
Study of medication timing of levocetirizine dihydrochloride in patients with recalcitrant chronic urticaria to anti-histamine drug
Scientific Title:Acronym
Study of medication timing of levocetirizine in patients with recalcitrant chronic urticaria
Region
| Japan |
Condition
Condition
Chronic urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The prone hour for chronic urticaria varies in every patient. Because a medical package insert recommends to take medicine in the suggested timing, patients usually do not take medicine immediately after the lesion develops. If standard dosage of medicine is not effective, to increase the dosage is one possibility. However, the most effective timing for taking increased dose has not been studied yet. We want to elucidate the desirable timing for taking increased dose. The aim of this study is to investigate the suitable timing for taking increased dose as for levocetirizine (Xyzal®), a second generation anti-histamine drug.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
degree of pruritus
Key secondary outcomes
adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
levocetirizine 10mg daily before sleep
Interventions/Control_2
levocetirizine 5mg daily before sleep and levocetirizine 5mg anytime the lesion exacerbate
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with recarcitrant chronic urticaria
Key exclusion criteria
1. Patients with acute infectious disease
2. Patients who are treated with ultra-violet therapy or hyposensitization therapy
3. Patients who engaged in dangerous job such as driving a car
4. Patients who were treated with systemic steroids less than 2 weeks prior to the initiation of this study
5. Patients who are pregnant or has possibility to be pregnant, and who are lactating
6. Patients who suffered from grave liver, renal, or heart disease
7. Patients who do not have hypertension, diabetes mellitus, or collagen disease
8. Patients who are considered inappropriate to be enrolled in this study by the doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yohei Natsuaki |
Organization
Kurume University School of Medicine
Division name
Department of Dermatology
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
+81-942-31-7571
natsuaki@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Natsuaki |
Organization
Kurume University School of Medicine
Division name
Department of Dermatology
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
+81-942-31-7571
Homepage URL
natsuaki@med.kurume-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2014 | Year | 04 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 05 | 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 | 04 | Month | 21 | Day |
Last modified on
| 2016 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015971
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
