UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008062 |
|---|---|
| Receipt number | R000009499 |
| Scientific Title | A study evaluating efficacy of non-sedative antihistamine up-titration in patients with chronic urticaria who did not respond to standard therapy. |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2014/04/22 16:49:11 |
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Basic information
Public title
A study evaluating efficacy of non-sedative antihistamine up-titration in patients with chronic urticaria who did not respond to standard therapy.
Acronym
UPDATE trial:Up-dosing antihistamine trial
Scientific Title
A study evaluating efficacy of non-sedative antihistamine up-titration in patients with chronic urticaria who did not respond to standard therapy.
Scientific Title:Acronym
UPDATE trial:Up-dosing antihistamine trial
Region
| Japan |
Condition
Condition
chronic urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of up-titration vs. fixed doses of antihistamine on clinical response, safety and QOL in patients with chronic urticaria that do not respond well to usual doses of antihistamines, using bepotastine besilate as one of the clinically widely used antihistamines.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
- Improvement in the degree of itching in the daytime and nighttime
Key secondary outcomes
- Improvement in the duration of rash
- Improvement in the degree of skin eruption (erythema, wheal, area/ extent)
- Change in QOL (Skindex-16)
- Overall improvement rating (degree of skin eruption, degree of itching)
- Degree of satisfaction regarding efficacy
- Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
14 days-treatment with bepotastine besilate(20mg x twice/day)
Interventions/Control_2
14 days-treatment with bepotastine besilate(10mg x twice/day)
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been diagnosed with chronic urticaria.
2) Patients having urticaria with a severity level of 3 or higher according to "Guidelines for the Diagnosis and Treatment of Urticaria and Angioedema" after treatment with oral bepotastine besilate for 2 weeks.
3) Patients who received an explanation of the study detail and signed a written consent form.
4) Patients aged 16 years or older at the time of registration. For those under 20 years, their guardians must also have signed the consent form.
Key exclusion criteria
1) Patients with a known allergy to any component of the study drug.
2) Pregnant or possibly pregnant women, or breastfeeding women. Women who wish to become pregnant during study participation.
3) Patients who are judged inappropriate to participate in the study by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Kawashima/Yoshiki Miyachi |
Organization
Tokyo Woman's Medical University/
Kyoto University Graduate School of Medicine
Division name
Dermatology/Dermatology
Zip code
Address
8-1 Kawada-cho,Shinjyuku-ku,Tokyo 162-8666,Japan/Yoshidakonoecho Kyoto Sakyo-ku, Kyoto 606-8315,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
EBMs Co.,Ltd
Division name
Business Strategy Division
Zip code
Address
World Trade Center Bldg. 24F 2-4-1, Hamamatsu-cho, Minato-ku, Tokyo 105-6124 Japan
TEL
Homepage URL
Sponsor or person
Institute
Non-Profit Organization Health Institute Research of Skin
Institute
Department
Personal name
Funding Source
Organization
Non-Profit Organization Health Institute Research of Skin
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
| 2012 | Year | 06 | Month | 01 | 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
| 2012 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
| 2012 | Year | 05 | Month | 31 | Day |
Last modified on
| 2014 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009499
