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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024027
Receipt No. R000027667
Scientific Title Clinical study to examine the changes of purine compounds by the simultaneous administration of xanthine oxidase/xanthine dehydrogenase inhibitors and inosine in healthy subjects.
Date of disclosure of the study information 2017/02/26
Last modified on 2017/12/20

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Basic information
Public title Clinical study to examine the changes of purine compounds by the simultaneous administration of xanthine oxidase/xanthine dehydrogenase inhibitors and inosine in healthy subjects.
Acronym Study of XO/XDH inhibitors and inosine in healthy subjects
Scientific Title Clinical study to examine the changes of purine compounds by the simultaneous administration of xanthine oxidase/xanthine dehydrogenase inhibitors and inosine in healthy subjects.
Scientific Title:Acronym Study of XO/XDH inhibitors and inosine in healthy subjects
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the changes of purine compounds in the blood by the simultaneous administration of xanthine oxidase/xanthine dehydrogenase inhibitors and inosine.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes Changes of purine compounds in the blood
Key secondary outcomes 1. Comparisons of means of purine compounds before and after treatment in each group.
2. Comparisons of means of changes of purine compounds between groups.

Base
Study type Interventional

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

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Allopurinol 100 mg and inosine 0.5 g twice a day for 14 days
Interventions/Control_2 Topiroxostat 60 mg and inosine 0.5 g twice a day for 14 days
Interventions/Control_3 Topiroxostat 80 mg and inosine 0.5 g twice a day for 14 days
Interventions/Control_4 Febuxostat 20 mg and inosine 0.5 g twice a day for 14 days
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
40 years-old >=
Gender Male
Key inclusion criteria 1) Healthy adult Japanese male
2) Subject with the ability to express his consent who, after a full explanation of the objective and contents of the present clinical study, has voluntarily expressed his consent to participate in the present clinical study.
3) Japanese subject with the age on the day of informed consent of not lower than 20 and not higher than 40.
4) Subject whose BMI is not lower than 17.6 and lower than 26.5 on the day of screening).
Key exclusion criteria 1) Routine user of medicine or supplement.
2) Subject who is currently being treated.
3) Subject who has or had renal function disorder.
4) Subject with a history of gout, hyperuricemia or urolithiasis.
5) Subject who has a history of renal disorder.
6) Subject who has or had hypersensitivity, idiosyncracy (allergy) to drug.
7) Subject with a disease or a disorder in heart, kidney, pulmonary organ, digestive organ or blood function that are considered to affect absorption, distribution, metabolism or excretion of a drug.
8) Subject who participated in another clinical study for a drug with a new compound within 4 weeks before the administration of drug in the present sduty.
9) Subject who donated 400 mL of blood within 12 weeks, 200 mL of blood within 4 weeks or blood components within 2 weeks.
10) Subject who used other drugs (including herbs) or supplements within 2 weeks before the administration of drug in this study.
11) Sujbect who plans to take other drugs (including herbs) or supplements before the end of the present study.
12) Subject who was judged not to be appropriate by the principal investigator or sub investigators by other reasons.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoyuki Kamatani
Organization Tsukuba International Clinical Pharmacology Clinic
Division name Doctors' office
Zip code
Address 1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
TEL 029-839-1150
Email kamatani@msb.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Suzuki
Organization Tsukuba International Clinical Pharmacology Clinic
Division name Division for Volunteers
Zip code
Address 1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
TEL 029-839-1150
Homepage URL
Email m-suzuki@tsukuba-icp.jp

Sponsor
Institute Tsukuba International Clinical Pharmacology Clinic
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
2017 Year 02 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/gnam/41/2/41_171/_pdf/
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 08 Month 03 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 22 Day
Last follow-up date
2016 Year 09 Month 03 Day
Date of closure to data entry
2016 Year 09 Month 30 Day
Date trial data considered complete
2016 Year 10 Month 10 Day
Date analysis concluded
2017 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 13 Day
Last modified on
2017 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027667

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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