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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029308
Receipt No. R000033501
Scientific Title Study on efficacy and safety as well as on the changes in blood purine compounds by the treatment of patients with amyotrophic lateral sclerosis with febuxostat and inosine in combination.
Date of disclosure of the study information 2018/09/30
Last modified on 2017/09/27

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Basic information
Public title Study on efficacy and safety as well as on the changes in blood purine compounds by the treatment of patients with amyotrophic lateral sclerosis with febuxostat and inosine in combination.
Acronym Effect of febuxostat and inosine on amyotrophic lateral sclerosis
Scientific Title Study on efficacy and safety as well as on the changes in blood purine compounds by the treatment of patients with amyotrophic lateral sclerosis with febuxostat and inosine in combination.
Scientific Title:Acronym Effect of febuxostat and inosine on amyotrophic lateral sclerosis
Region
Japan

Condition
Condition Amyotrophic lateral sclerosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine efficacy and safety of simultaneous administration of febuxostat and inosine for patients with amyotrophic lateral sclerosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Difference of ALSFRS-R between before and after the treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Febuxostat 20 mg, Inosine 500 mg, twice a day for 14 days
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Japanese patients with 20 to 80 years of age who are the outpatients of Teikyo University Hospital
2. Patients who have been diagnosed as amyotrophic lateral sclerosis
Key exclusion criteria 1. Subject who has or had hypersensitivity, idiosyncracy (allergy) to drug.
2. Subjects taking azathioprine or mercaptopurine
3. Subject who has or had renal function disorder.
4. Subject with a history of gout, hyperuricemia or urolithiasis.
5. Patients who changed therapeutic drugs and treatment methods within 1 month before administration of test drugs
6. Subject who was judged not to be appropriate by the principal investigator or sub investigators by other reasons.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumiaki Saito
Organization Teikyo University
Division name Department of neurology, Faculty of Medicine
Zip code
Address 11-1, Kaga 2-chome, Itabashi-ku, Tokyo 173-8606, Japan
TEL 03-3964-1211
Email f-saito@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumiaki Saito
Organization Teikyo University
Division name Department of neurology, Faculty of Medicine
Zip code
Address 11-1, Kaga 2-chome, Itabashi-ku, Tokyo 173-8606, Japan
TEL 03-3964-1211
Homepage URL
Email f-saito@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization StaGen 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 09 Month 30 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
2016 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 18 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
2017 Year 09 Month 27 Day
Last modified on
2017 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033501

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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