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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043600
Receipt No. R000049750
Scientific Title THALED CAPSULES Specified Drug Use-results Survey (Crow-Fukase (POEMS) syndrome: Long-term Use)
Date of disclosure of the study information 2021/03/15
Last modified on 2021/03/09

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Basic information
Public title THALED CAPSULES Specified Drug Use-results Survey (Crow-Fukase (POEMS) syndrome: Long-term Use)
Acronym THALED CAPSULES Specified Drug Use-results Survey (Crow-Fukase (POEMS) syndrome: Long-term Use)
Scientific Title THALED CAPSULES Specified Drug Use-results Survey (Crow-Fukase (POEMS) syndrome: Long-term Use)
Scientific Title:Acronym THALED CAPSULES Specified Drug Use-results Survey (Crow-Fukase (POEMS) syndrome: Long-term Use)
Region
Japan

Condition
Condition Crow-Fukase (POEMS) syndrome
Classification by specialty
Hematology and clinical oncology Neurology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety and efficacy at long-term use of THALED CAPSULES in patient with Crow-Fukase (POEMS) syndrome
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety (adverse drug reactions)
Key secondary outcomes Efficacy (Serum VEGF reduction rate, modified Rankin Scale, Overall Neuropathy Limitation Scale, PFS, OS)

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with POEMS syndrome who will receive the treatment with THALED CAPSULES
Key exclusion criteria NA
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Chikako
Middle name
Last name Nakao
Organization Fujimoto Pharmaceutical Corp.
Division name Department of Pharmacovigilance and Data science
Zip code 580-8503
Address 1-3-40, Nishiotsuka, Matsubara, Osaka 580-8503, Japan
TEL 072-332-5151
Email pms@fujimoto-pharm.co.jp

Public contact
Name of contact person
1st name Masanao
Middle name
Last name Nakatani
Organization Fujimoto Pharmaceutical Corp.
Division name Department of Pharmacovigilance and Data science
Zip code 580-8503
Address 1-3-40, Nishiotsuka, Matsubara, Osaka 580-8503, Japan
TEL 072-332-5151
Homepage URL
Email pms@fujimoto-pharm.co.jp

Sponsor
Institute Fujimoto Pharmaceutical Corp.
Institute
Department

Funding Source
Organization Fujimoto Pharmaceutical Corp.
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 Not applicable
Address Not applicable
Tel Not applicable
Email Not applicable

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
2021 Year 03 Month 15 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 Open public recruiting
Date of protocol fixation
2021 Year 02 Month 01 Day
Date of IRB
2021 Year 02 Month 01 Day
Anticipated trial start date
2021 Year 02 Month 24 Day
Last follow-up date
2027 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Approval by IRB is not necessary.

Management information
Registered date
2021 Year 03 Month 12 Day
Last modified on
2021 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049750

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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