UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031332 |
|---|---|
| Receipt number | R000035765 |
| Scientific Title | Drug use-results survey on safety and efficacy of Rupafin tablets 10 mg |
| Date of disclosure of the study information | 2018/02/16 |
| Last modified on | 2021/03/01 11:08:05 |
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Basic information
Public title
Drug use-results survey on safety and efficacy of Rupafin tablets 10 mg
Acronym
Drug use-results survey on safety and efficacy of Rupafin tablets 10 mg
Scientific Title
Drug use-results survey on safety and efficacy of Rupafin tablets 10 mg
Scientific Title:Acronym
Drug use-results survey on safety and efficacy of Rupafin tablets 10 mg
Region
| Japan |
Condition
Condition
Allergic rhinitis
Hives and itch associated with skin diseases ( eczema / dermatitis, cutaneous pruritus)
Classification by specialty
| Clinical immunology | Dermatology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess safety and efficacy of Rupafin Tablets 10mg under actual use conditions.
To assess safety and efficacy of Rupafin Tablets 10mg in children age over 12 and elder age over 65 under actual use conditions.
To assess development of somnolence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety(Adverse Drug Reaction)
Effectiveness(Assessment by physician)
Key secondary outcomes
Effectiveness(Condition of symptoms for each indication during the medication)
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients newly treated by RUPAFIN
Key exclusion criteria
Patients with a history of hypersensitivity to the active substance or to any of the excipients.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ich Hisaichi |
Organization
TEIKOKU SEIYAKU CO.,LTD.
Division name
Safety Management Unit
Zip code
Address
567 Sanbonmatsu, Higashikagawa, Kagawa
TEL
0879-25-2435
gpsp@teiyaku.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Horikawa, Kazuhito Okada |
Organization
TEIKOKU SEIYAKU CO.,LTD.
Division name
Safety Management Unit
Zip code
Address
567 Sanbonmatsu, Higashikagawa, Kagawa
TEL
0879-25-2435
Homepage URL
gpsp@teiyaku.co.jp
Sponsor or person
Institute
TEIKOKU SEIYAKU CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
TEIKOKU SEIYAKU CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
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 | 02 | Month | 16 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Drug use result survey
Management information
Registered date
| 2018 | Year | 02 | Month | 16 | Day |
Last modified on
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035765
