UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008752
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

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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 or person

Institute

Kanazawa Medical University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010277


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name