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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009262
Receipt No. R000010875
Scientific Title effects of Uric-acid-lowering agent, FebuxOstat on subclinical inflammation in patients with hyperuricemia (UFO study)
Date of disclosure of the study information 2012/11/05
Last modified on 2015/05/07

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Basic information
Public title effects of Uric-acid-lowering agent, FebuxOstat on subclinical inflammation in patients with hyperuricemia (UFO study)
Acronym effects of Uric-acid-lowering agent, FebuxOstat on subclinical inflammation in patients with hyperuricemia (UFO study)
Scientific Title effects of Uric-acid-lowering agent, FebuxOstat on subclinical inflammation in patients with hyperuricemia (UFO study)
Scientific Title:Acronym effects of Uric-acid-lowering agent, FebuxOstat on subclinical inflammation in patients with hyperuricemia (UFO study)
Region
Japan

Condition
Condition hyperuricemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of febuxostat on markers of metabolic syndrome and atherosclerosis, including high sensitivity C-reactive protein, in patients with hyperuricemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes serum high sensitivity C-reactive protein (CRP)
Key secondary outcomes (1) Changes of HOMA-IR between two groups
(2) Changes of IMT, PWV
(3) Effects on factors of metabolic syndrome (abdominal, blood pressure, fat, blood glucose)
(4) Change of serum uric acid levels and achiving less than 6.0mg/dl of uric acid levels,
(5) Changes of eGFR
(6) Changes of albuminuria/creatinine
(7) Changes of serum and urine biomarkers

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 febuxostat + life style modification
Interventions/Control_2 life style modification
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
100 years-old >=
Gender Male
Key inclusion criteria (1) serum urate levels higher than 7.0 mg/dl
(2) not treated with urate reducing drugs for 1 month
(3) other complications including hypertension, dyslipidemia and diabetes are in stable
(4)written informed consent obtained from the participants
Key exclusion criteria (1) patients with history of gout
(2) patients with malignancy, or other serious illness
(3) patients with allergy to febuxostat
(4) patients treated with mercaptopurine or azathioprine
(5) patients not recognized as appropriate to participate
(6) patients under insulin treatment
(7) serum creatinine levels higher than 1.5 mg/dl
(8) patients with inflammatory disease such as rheumatic diseases or inflammatory bowel diseases
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yamamoto, Tetsuya
Organization Hyogo College of Medicine
Division name Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya City, Hyogo 663-8501
TEL 0798-45-6473
Email tetsuya@hyo-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Koyama, Hidenori
Organization Hyogo College of Medicine
Division name Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya City, Hyogo 663-8501
TEL 0798-45-6473
Homepage URL
Email hkoyama@hyo-med.ac.jp

Sponsor
Institute UFO study Investigators
Institute
Department

Funding Source
Organization TEIJIN Pharmaceutical
Organization
Division
Category of Funding Organization Profit organization
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 11 Month 05 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 Open public recruiting
Date of protocol fixation
2012 Year 11 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 05 Day
Last modified on
2015 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010875

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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