UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035765