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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031332
Receipt No. 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 2020/04/01

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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
Email 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
Email gpsp@teiyaku.co.jp

Sponsor
Institute TEIKOKU SEIYAKU CO.,LTD.
Institute
Department

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
Email

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 No longer recruiting
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
2020 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035765

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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