UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012187 |
|---|---|
| Receipt number | R000014246 |
| Scientific Title | Examination of the effectiveness of bepotastine besilate administration to the inducer and itching of atopic dermatitis patients |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2023/11/09 00:41:44 |
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Basic information
Public title
Examination of the effectiveness of bepotastine besilate administration to the inducer and itching of atopic dermatitis patients
Acronym
Examination of the effectiveness of bepotastine besilate administration to the inducer and itching of atopic dermatitis patients
Scientific Title
Examination of the effectiveness of bepotastine besilate administration to the inducer and itching of atopic dermatitis patients
Scientific Title:Acronym
Examination of the effectiveness of bepotastine besilate administration to the inducer and itching of atopic dermatitis patients
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effectiveness of bepotastine besilate administration to the inducer and itching of atopic dermatitis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL (Dermatology Life Quality Index)
Pruritus (Visual Analog Scale)
Safety and sleepiness (Visual Analog Scale)
Severity (day skin simplified method)
before Administered / after 2 weeks / 4 weeks
Key secondary outcomes
Tryptase
Cortisol
TARC
before Administered / after 2 weeks / 4 weeks
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The administration of the Tarion 10mg / 2 times / day: 4 weeks from the start of the study
(Increase or decrease accordingly 20mg 2 minutes)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
· (Itching and VAS> 30) patients who do not itch disappearance of the only topical steroid in adult atopic dermatitis.
· It is 20 years of age or older.
• After you have received a sufficient explanation to study entry, document consent free will of the patient himself has been obtained on a thorough understanding.
Key exclusion criteria
Atopic dermatitis patients with severe
for example
Cases it is necessary to continue using drugs that seem to affect the response evaluation of test agent within a week before, antiallergic agents, antihistamines, oral steroids, and cyclosporine oral medicine.
Patients having serious complications liver disease, kidney disease, heart disease, and other attending physician deems inappropriate.
Dialysis patients and patients taking opioid be assumed pruritus central.
Potential cases of lactating women, pregnant or are pregnant.
Other patients attending physician deems inappropriate incorporation into the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takasuke Ogawa |
Organization
Juntendo university hospital
Division name
Departoment of dermatorogy
Zip code
Address
2-1-1 Hongo,Bunkyoku,Tokyo,Japan
TEL
03-3813-3111
t-ogawa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takasuke Ogawa |
Organization
Juntendo university hospital
Division name
Departoment of dermatorogy
Zip code
Address
2-1-1 Hongo,Bunkyoku,Tokyo,Japan
TEL
03-3813-311
Homepage URL
t-ogawa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University (Graduate School)
hospital departoment dermatorogy
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
| 2013 | Year | 11 | Month | 01 | 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
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 31 | Day |
Last modified on
| 2023 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014246
