UMIN-CTR Clinical Trial

Basic information
Public 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".
Acronym	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".
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".
Scientific Title:Acronym	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".
Region	Japan

Condition
Condition	Urolithiasis patients with hyperuricemia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	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	Feburic tablets
Interventions/Control_2	Uralyt
Interventions/Control_3	Feburic tablets and Uralyt
Interventions/Control_4	No medication
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	Not applicable
Gender	Male
Key inclusion criteria	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.
Key exclusion criteria	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.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koji Suzuki
Organization	Kanazawa Medical University
Division name	Urology
Zip code
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL	076-286-2211
Email

Public contact
Name of contact person	1st name Middle name Last name Katsuhito Miyazawa
Organization	Kanazawa Medical University
Division name	Urology
Zip code
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
Homepage URL
Email

Sponsor
Institute	Kanazawa Medical University
Institute
Department

Funding Source
Organization	Kanazawa Medical University
Organization
Division
Category of Funding Organization	Self funding
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	2012 Year 08 Month 23 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	2012 Year 06 Month 29 Day
Date of IRB	2012 Year 07 Month 25 Day
Anticipated trial start date	2012 Year 08 Month 23 Day
Last follow-up date	2018 Year 10 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 08 Month 23 Day
Last modified on	2022 Year 02 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010277