UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007362
Receipt number R000008662
Scientific Title An investigation of the serum uric acid-lowering effects of febuxostat in gout/hyperuricemia patients according to disease type
Date of disclosure of the study information 2012/02/23
Last modified on 2013/09/10 18:44:53

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Basic information

Public title

An investigation of the serum uric acid-lowering effects of febuxostat in gout/hyperuricemia patients according to disease type

Acronym

FORTUNE-2

Scientific Title

An investigation of the serum uric acid-lowering effects of febuxostat in gout/hyperuricemia patients according to disease type

Scientific Title:Acronym

FORTUNE-2

Region

Japan


Condition

Condition

Hyperuricemia and gout

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

An open-label, non-comparative study on the serum uric acid-lowering effects of febuxostat in gout/hyperuricemia patients according to disease type

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The serum uric acid-lowering rate at Week 12

Key secondary outcomes

- The goal attainment rate for serum uric acid level of 6.0 mg/dL or lower at Week 12
- The uric acid-lowering effects at Weeks 4 and 8 [serum uric acid-lowering rate, goal attainment rate (serum uric acid level of 6.0 mg/dL or lower)]


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who fulfill all three of the criteria below are eligible for the study:
1) Gout/hyperuricemia patients who have not been treated with any uric acid-lowering drugs during the two weeks prior to obtainment of informed consent and have serum uric acid level of 7.0 mg/dL or higher
2) Patients aged 20 years or older at the time of obtainment of informed consent (regardless of sex and inpatient/outpatient status)
3) Patients who consent in writing to participate in the study

Key exclusion criteria

Patients who meet any of the 10 criteria below are ineligible for the study:
1) Patients who have a past history of hypersensitivity to febuxostat
2) Secondary hyperuricemia patients
3) Patients who have twice as high AST or ALT as the hospital's reference value
4) Males with serum creatinine level of 2.0 mg/dL or higher and females with serum creatinine level of 1.5 mg/dL or higher
5) Patients who have or have had past history of malignant tumor as a complication requiring treatment
6) Patients who are being treated with either mercaptopurine hydrate or azathioprine
7) Patients who are undergoing hormone replacement therapy (HRT)
8) Patients who are or are likely to become pregnant, and those who are lactating
9) Patients who participated in another clinical study or clinical trial in the six months prior to the confirmation of eligibility
10) Patients who the doctor in charge judges are ineligible for the study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Yamamoto

Organization

Hyogo College of Medicine

Division name

Endocrinology and Metabolism, Department of Internal Medicine

Zip code


Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo

TEL

0798-45-6472

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takashi Oi

Organization

Mebix, Inc.

Division name

Clinical Research III

Zip code


Address

1-11-44 Akasaka, Minato-ku, Tokyo, Japan

TEL

03-6229-8936

Homepage URL


Email

fortune@mebix.co.jp


Sponsor or person

Institute

Clinical research consortium on uric acid

Institute

Department

Personal name



Funding Source

Organization

Teijin Pharma Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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 02 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 01 Month 31 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2013 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

NA


Management information

Registered date

2012 Year 02 Month 23 Day

Last modified on

2013 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008662


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name