UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046735 |
|---|---|
| Receipt number | R000053320 |
| Scientific Title | Effect on blood uric acid level after switching from existing uric acid lowering drugs to URECE tablets (preliminary test) |
| Date of disclosure of the study information | 2022/01/31 |
| Last modified on | 2023/07/26 10:10:22 |
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Basic information
Public title
Clinical study on changes in blood uric acid levels after switching from existing uric acid lowering drugs to URECE tablets
(preliminary test)
Acronym
Effect on blood uric acid levels after switching from existing uric acid lowering drugs to URECE tablets
(preliminary test)
Scientific Title
Effect on blood uric acid level after switching from existing uric acid lowering drugs to URECE tablets
(preliminary test)
Scientific Title:Acronym
Effect on blood uric acid level after switching from existing uric acid lowering drugs to URECE tablets (preliminary test)
Region
| Japan |
Condition
Condition
Hyperuricemia
Classification by specialty
| Medicine in general | Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Check for a smooth transition from existing uric acid-lowering drugs to URECE tablets.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect on blood uric acid level
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Switch from existing uric acid lowering medication to URECE tablets, starting at 0.5 mg/day for 8 weeks. Blood samples will be taken before, 1 day after, 3 days after, 1 week after, 4 weeks after, and 8 weeks after the switch.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A person who fully understands and agrees to the purpose of this research and possible adverse events as clearly stated in the Research Cooperation Agreement. Those who have signed the consent form for cooperation.
Those who are 30 years of age or older at the time of obtaining consent (excluding students of their own schools).
Those who are taking existing uric acid lowering medication daily.
Key exclusion criteria
If the subject feels that the research itself is a burden to his/her daily life.
Subjects who are judged by the principal investigator or sub-investigator to be ineligible for the study.
Those who have contraindications to the administration of the study drug URECE Tablets used in the study.
Those who have gout attack.
Patients with urinary tract stones, or patients with a history of urinary tract stones.
Patients with severe hepatic or renal impairment or cardiac disease.
Pregnant women and lactating women.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Takuo |
| Middle name | |
| Last name | Ogihara |
Organization
Takasaki University of Health and Welfare
Division name
Graduate School of Pharmaceutical Sciences
Zip code
370-0033
Address
60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
027-352-1180
togihara@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Satsuki |
| Middle name | |
| Last name | Kimura |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Pharmacy
Zip code
370-0033
Address
60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
027-352-1180
Homepage URL
s-kimura@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Kendai Translational Research Center
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
The Research Ethics Committee at Takasaki University of Health and Welfare
Address
37-1 Nakaorui-machi, Takasaki-shi, Gunma, Japan
Tel
027-352-1290
kuwabara@takasaki-u.ac.jp
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
高崎健康福祉大学附属クリニック
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | 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
| 2022 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 26 | Day |
Last modified on
| 2023 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053320
