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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007362
Receipt No. 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

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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
Institute Clinical research consortium on uric acid
Institute
Department

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
URL(English) https://upload.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


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