UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047616 |
|---|---|
| Receipt number | R000054297 |
| Scientific Title | Treatment satisfaction by web survey for chronic spontaneous urticaria in Japan |
| Date of disclosure of the study information | 2022/05/02 |
| Last modified on | 2023/09/22 14:14:52 |
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Basic information
Public title
Treatment satisfaction by web survey for chronic spontaneous urticaria in Japan
Acronym
Treatment satisfaction survey for chronic spontaneous urticaria in Japan
Scientific Title
Treatment satisfaction by web survey for chronic spontaneous urticaria in Japan
Scientific Title:Acronym
Treatment satisfaction survey for chronic spontaneous urticaria in Japan
Region
| Japan |
Condition
Condition
chronic spontaneous urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the level of satisfaction with treatment in patients with chronic spontaneous urticaria and the items associated with treatment satisfaction, and perform sub-analysis by subgroup
Basic objectives2
Others
Basic objectives -Others
satisfaction with treatment
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
- Summary statistics (e.g., average) of TSQM-9 score
- Correlation coefficient between TSQM-9 score and UCT/DLQI/Itch-NRS/Burning sensation NRS/Sleep NRS/SF-8/WPAI:GH score
- TSQM-9 score by demographic characteristic
- TSQM-9 score by treatment
Key secondary outcomes
- Summary statistics (e.g, average) of UCT/DLQI/SF-8/WPAI:GH scores
- Responses to each NRS
- Each score by demographic characteristic
- Each score by treatment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
- Those who submit their informed consent and agree to participate in the survey
- Those who stated that they have been diagnosed with chronic spontaneous urticaria or chronic urticaria by a physician in the past
- Those who stated that their urticaria had continued more than 6 weeks with no trigger in the past
- Those who have received some sort of treatment for chronic spontaneous urticaria or chronic urticaria within the past 3 months
- Males and females who are 20 years old or older, reside in Japan, and can understand and answer the questionnaire in Japanese
Key exclusion criteria
- Correspond to an inappropriate answer
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | FUJITA |
Organization
Sanofi K.K.
Division name
Dermatology Medical, Immunology Medical, Specialty Care
Zip code
163-1488
Address
Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6301-3000
Hiroyuki2.Fujita@sanofi.com
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | KISHI |
Organization
Sanofi K.K.
Division name
Dermatology Medical, Immunology Medical, Specialty Care
Zip code
163-1488
Address
Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6301-4575
Homepage URL
Sanofi_Medical@sanofi.com
Sponsor or person
Institute
Sanofi K.K.
Institute
Department
Personal name
Funding Source
Organization
Sanofi K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitamachi Clinic
Address
1-1-3 Kitamachi, Kichijoji, Musashino-city, Tokyo
Tel
03-6779-8166
chi-pr-ec-kitamachi@cmicgroup.com
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
該当なし/not applicable
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
N/A (not available)
Publication of results
Partially published
Result
URL related to results and publications
N/A (not available)
Number of participants that the trial has enrolled
550
Results
Antihistamines (66.0%) and topical steroids (TCS; 35.0%) were the most common drugs currently used, with 7.8% of patients taking both together. 12.1% of patients received oral steroids (OCS), 9.1% over-the-counter drugs only, and 2.6% anti-IgE antibody.
The mean (+/-SD) Global Satisfaction in TSQM-9 was 59.2 +/- 18.4 in the overall population, 59.6 +/- 18.0 for antihistamines, 56.4 +/- 18.5 for TCS, 55.2 +/- 20.9 for OCS, and 54.6 +/- 13.9 for anti-IgE antibody by current drugs.
Results date posted
| 2023 | Year | 09 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Mean +/- SD age 45.3 +/- 13.2 years old; 59.9% female; urticaria duration 13.2 +/- 13.0 years; UCT 9.7 +/- 3.4.
Participant flow
Enrolled individuals were those registered on the 2021 general consumer panel of Rakuten Insight Inc. (a market research company) and who were asked to participate voluntarily in an online questionnaire. All responses received within the survey period were accepted, collected as primary data, and anonymized by Rakuten Insight, Inc.
Adverse events
not collected
Outcome measures
The mean +/-SD Global Satisfaction in TSQM-9: 59.2 +/- 18.4 in the overall population; 59.6 +/- 18.0 for antihistamines, 56.4 +/- 18.5 for topical steroids, 55.2 +/- 20.9 for oral steroids, and 54.6 +/- 13.9 for anti-IgE antibody by current drugs.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 31 | Day |
Other
Other related information
Exploratory Outcomes
- Responses to QOL26 Questions
- Responses to QOL26 Questions by demographic characteristic
- Responses to QOL26 Questions by treatment
Management information
Registered date
| 2022 | Year | 04 | Month | 28 | Day |
Last modified on
| 2023 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054297
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