Phase III Trial of Febuxostat in Korea Gout Patients

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ClinicalTrials.gov Identifier: NCT00821392

Recruitment Status : Completed

First Posted : January 13, 2009

Last Update Posted : January 13, 2009

Sponsor:

Information provided by:

SK Chemicals Co.,Ltd.

Study Description

Brief Summary:

This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea

Condition or disease	Intervention/treatment	Phase
Gout	Drug: Febuxostat	Phase 3

Detailed Description:

This is a multi-center, randomized, double-blind, allopurinol and placebo controlled, parallel, 5 arms, dose response, bridging study of 4 weeks duration.

If subjects pass the screening evaluation after submitting a signed informed consent, they will be randomly assigned to one of the five treatment regimens; febuxostat 40mg, 80mg, 120mg, placebo or allopurinol 300mg. Colchicine 0.6mg QDis given to minimize the risk of gout flares during the washout/run-in period and during the double study period.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	181 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Randomized, Multi-Center, Double Blinded, Allopurinol-Controlled, Placebo-Controlled Parallel Group, 5-Arm, Dose-Response,Bridging Study to Assess the Efficacy and Safety of Febuxostat in Subject With Gout
Study Start Date :	August 2006
Actual Primary Completion Date :	September 2007
Actual Study Completion Date :	September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout

Drug Information available for: Febuxostat

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 Febuxostat 40mg	Drug: Febuxostat
Active Comparator: 2 Febuxostat 80mg	Drug: Febuxostat
Active Comparator: 3 Febuxostat 120mg	Drug: Febuxostat
Sham Comparator: 4 Allopurinol 300mg	Drug: Febuxostat
Placebo Comparator: 5 Placebo	Drug: Febuxostat

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age :18-85 years
female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception
female: negative serum pregnancy test
subjects who satisfy ARA (American Rheumatism Association)
subjects must have a renal function defined as: serum creatinine ≤ 1.5 mg/dL <Day -1>

1.serum urate level ≥8.0mg/dL 2.creatinine level ≤ 1.5mg/dL 3.subject continued to meet all inclusion and no exclusion criteria

Exclusion Criteria:

women who are breast-feeding or pregnant
a history of xanthinuria
allopurinol intolerance
receiving thiazide diuretic therapy
secondary hyperuricemia
required > 10mg/day of prednisone during the study stable dose(≤10mg/day), inhaled and intranasal steroids will be allowed.
concomitant therapy containing aspirin or other salicylates(systemic or topical, prescribed or non-prescribed) stable, low doses aspirin will be allowed(i.e. ≤325mg/day).
any change in hormone replacement therapy or oral contraceptive therapy within 3 months of the screening visit
alcohol intake≥ 14drinks/week alcohol abuse within 5 years or current excessive alcohol use was prohibited.
concomitant therapy with any urate-lowering therapy
active liver disease or hepatic dysfunction : ALT, AST ≥1.5 ULN
subject was unable to take colchicine or contradictory to colchicine
a serum urate level < 8.0mg/dL and not taking uric acid lowering therapy
rheumatoid arthritis or any active arthritis requiring for the medication treatment
a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the screening visit, or had taken any systemic cancer chemotherapy within 5 years prior to the screening visit
participated in another investigational trial within the 30days prior to the screening visit
any other significant medical condition as defined by the investigator

Contacts and Locations

No Contacts or Locations Provided

More Information


Responsible Party:	SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT00821392 History of Changes
Other Study ID Numbers:	TMX-67
First Posted:	January 13, 2009 Key Record Dates
Last Update Posted:	January 13, 2009
Last Verified:	October 2007

Additional relevant MeSH terms:


Gout Arthritis Joint Diseases Musculoskeletal Diseases Crystal Arthropathies Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Allopurinol	Febuxostat Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Gout Suppressants Antirheumatic Agents Free Radical Scavengers Antioxidants Protective Agents Physiological Effects of Drugs

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