UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024316 |
|---|---|
| Receipt number | R000028008 |
| Scientific Title | Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with glucose intolerance, and changes of blood and urine purine compounds. |
| Date of disclosure of the study information | 2017/08/31 |
| Last modified on | 2017/05/09 13:21:41 |
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Basic information
Public title
Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with glucose intolerance, and changes of blood and urine purine compounds.
Acronym
Effect of febuxostat and inosine on glucose intolerance
Scientific Title
Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with glucose intolerance, and changes of blood and urine purine compounds.
Scientific Title:Acronym
Effect of febuxostat and inosine on glucose intolerance
Region
| Japan |
Condition
Condition
glucose intolerance
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of efficacy and safety of the combined use of febuxostat and inosine for subjects with glucose intolerance, and changes of blood and urine purine compounds.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of blood glucose at 2 hours of glucose intolerance test between before and after the administration of febuxostat and inosine for 2 weeks
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
Administration of febuxostat 20 mg and inosine 0.5 g twice a day for 2 weeks
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese male adult who showed HbA1c of not lower than 6.5%, fasting blood glucose of not lower than 126 mg/dL, casual blood glucose of not lower than 200 mg/dL or abnormal glucose tolerance judged by glucose tolerance test during the latest 6 months.
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 with 20 to 60 years of age
4. Subject with BMI of not lower than 17.6 and lower than 28.0 on the day of screening test.
Key exclusion criteria
1. Routine user of medicine or supplement.
2. Subject who is currently being treated for diabetes.
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. Subjects taking azathioprine, mercaptopurine or other purine analogs
8. 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.
9. 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 study.
10. Subject who donated 400 mL of blood within 12 weeks, 200 mL of blood within 4 weeks or blood components within 2 weeks.
11. Subject who used other drugs (including herbs) or supplements within 2 weeks before the administration of drug in this study.
12. Sujbect who plans to take other drugs (including herbs) or supplements before the end of the present study.
13. Subject who was judged not to be appropriate by the principal investigator or sub investigators by other reasons.
Target sample size
5
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
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
m-suzuki@tsukuba-icp.jp
Sponsor or person
Institute
Tsukuba International Clinical Pharmacology Clinic
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
| 2017 | Year | 08 | Month | 31 | 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 | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 06 | Day |
Last modified on
| 2017 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028008
