UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029308 |
|---|---|
| Receipt number | 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 12:50:35 |
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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
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
f-saito@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033501
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
