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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005257
Receipt No. R000006254
Scientific Title Clinical trial of Bezafibrate for patients with long-chain fatty acid beta-oxydation disorder
Date of disclosure of the study information 2011/04/01
Last modified on 2018/12/14

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Basic information
Public title Clinical trial of Bezafibrate for patients with long-chain fatty acid beta-oxydation disorder
Acronym Clinical trial of Bezafibrate for patients with long-chain fatty acid beta-oxydation disorder
Scientific Title Clinical trial of Bezafibrate for patients with long-chain fatty acid beta-oxydation disorder
Scientific Title:Acronym Clinical trial of Bezafibrate for patients with long-chain fatty acid beta-oxydation disorder
Region
Japan

Condition
Condition long-chain fatty acid beta-oxydation disorder
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to investigate the effects of bezafibrate on patients with long-chain fatty acid beta-oxydation disorder
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes improvement of clinical symptoms (muscle pain etc.)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 bezafibrate for internal use
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 long-chain fatty acid beta-oxydation disorder
Key exclusion criteria a case who dosen't approve this clinical trial
Target sample size 2

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Awano
Organization Kobe University Graduate School of Medicine
Division name Psdiatrics
Zip code
Address 7-5-1,Kusunokicho, Chuo, Kobe, Japan
TEL 078-382-6090
Email awahiro@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Awano
Organization Kobe University Graduate School of Medicine
Division name Pediatrics
Zip code
Address 7-5-1, Kusunokicho, Chuo, Kobe, Japan
TEL 078-382-6090
Homepage URL
Email awahiro@med.kobe-u.ac.jp

Sponsor
Institute Department of Pediatrics, Kobe University Graduate School of Medicine,
Institute
Department

Funding Source
Organization Grant-in aid for Scientific Resaerch (KAKENHI)
Organization
Division
Category of Funding Organization Other
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
2011 Year 04 Month 01 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
2011 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 16 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006254

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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