Unique ID issued by UMIN | UMIN000008752 |
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Receipt number | R000010277 |
Scientific Title | Evaluation of efficacy of urinary uric acid excretion and urolithiasis related factor in urolithiasis patients with hyperuricemia by combination therapies of "Feburic tablets" and "Uralyt". |
Date of disclosure of the study information | 2012/08/23 |
Last modified on | 2022/02/28 19:57:18 |
Evaluation of efficacy of urinary uric acid excretion and urolithiasis related factor in urolithiasis patients with hyperuricemia by combination therapies of "Feburic tablets" and "Uralyt".
Evaluation of efficacy of urinary uric acid excretion and urolithiasis related factor in urolithiasis patients with hyperuricemia by combination therapies of "Feburic tablets" and "Uralyt".
Evaluation of efficacy of urinary uric acid excretion and urolithiasis related factor in urolithiasis patients with hyperuricemia by combination therapies of "Feburic tablets" and "Uralyt".
Evaluation of efficacy of urinary uric acid excretion and urolithiasis related factor in urolithiasis patients with hyperuricemia by combination therapies of "Feburic tablets" and "Uralyt".
Japan |
Urolithiasis patients with hyperuricemia
Urology |
Others
NO
Evaluation of changes in the amount of uric acid excretion due to decreased serum uric acid level by "Feburic tablets".
Evaluation of additional benefit by the combined use alkalinizing agent.
Evaluation of prevention of recurrence of urolithiasis by exploring the factors associated with urolithiasis.
Safety,Efficacy
Change of the clinical laboratory test result in four weeks of study, and the degree of super saturation of a calcium oxalate or calcium phosphate.
Interventional
Parallel
Randomized
Open -no one is blinded
Active
4
Treatment
Medicine |
Feburic tablets
Uralyt
Feburic tablets and Uralyt
No medication
20 | years-old | <= |
Not applicable |
Male
1) More than 20 years old Japanese male patient age at the time of obtaining informed consent.
2) Patients with serum uric acid level are greater than 7.0mg/dl.
3) Patient in the previous two weeks, not taking uric acid-lowering drugs.
4) Informed consent.
1) The patient who is developing gouty arthritis at the time of an eligibility judging, or has not passed two weeks since a gout arthritis disappearance day.
2) The patient who has not passed two weeks since the last medication day of the following combined use prohibition medicine at the time of an eligibility judging.
Combined use prohibition drug of "Febric tablets".
Mercaptopurine hydrate
Azathioprine
Combined use prohibition drug of "Uralyt".
Hexamine mandelate
3) Serum creatinine level is more than 1.5 mg/dl.
4) Liver disease patients (either AST or ALT exceeds the twice of a standard value maximum).
5) Patients with severe cardiac disease, renal failure and other critical diseases.
6) Patients with drug allergy.
7) Patients who are considered to be inappropriate by the investigators.
40
1st name | |
Middle name | |
Last name | Koji Suzuki |
Kanazawa Medical University
Urology
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
076-286-2211
1st name | |
Middle name | |
Last name | Katsuhito Miyazawa |
Kanazawa Medical University
Urology
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
Kanazawa Medical University
Kanazawa Medical University
Self funding
NO
2012 | Year | 08 | Month | 23 | Day |
Unpublished
Completed
2012 | Year | 06 | Month | 29 | Day |
2012 | Year | 07 | Month | 25 | Day |
2012 | Year | 08 | Month | 23 | Day |
2018 | Year | 10 | Month | 11 | Day |
2012 | Year | 08 | Month | 23 | Day |
2022 | Year | 02 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010277
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