Study to Assess the Long-Term Safety of Febuxostat in Subjects With Gout. - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00174941

Purpose

A Phase 2, study to evaluate the long-term safety of febuxostat at doses (40, 80, and 120 mg QD) expected to maintain serum urate levels within clinically acceptable levels in subjects with gout.

Condition	Intervention	Phase
Gout	Drug: Febuxostat 40 mg Drug: Febuxostat 80 mg Drug: Febuxostat 120 mg	Phase II

MedlinePlus related topics: Gout

Drug Information available for: Tei 6720

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II, Open-Label Study, to Assess the Long-Term Safety of Oral TMX-67 in Subjects With Gout

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Proportion of subjects whose serum uric acid level decreases to or is maintained at <6.0mg/dL. [ Time Frame: Every visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent reduction in serum urate levels from baseline. [ Time Frame: Every visit ] [ Designated as safety issue: No ]

Enrollment:	116
Study Start Date:	March 2001
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Febuxostat 40 mg	Drug: Febuxostat 40 mg Daily orally for 5 years
2: Experimental Febuxostat 80 mg	Drug: Febuxostat 80 mg Daily orally for 5 years
3: Experimental Febuxostat 120 mg	Drug: Febuxostat 120 mg Daily orally for 5 years

Detailed Description:

A Phase 2, open label study to evaluate the long-term safety of febuxostat at doses (40, 80, and 120 mg QD) expected to maintain serum urate levels within clinically acceptable levels in subjects with gout. Subjects will have successfully completed study TMX-00-004

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hyperuricemia (serum uric acid ≥8.0 mg/dL upon entering parent study TMX-00-004)
Must meet ARA criteria for gout
Must have adequate renal function (serum creatinine <1.5 mg/dL)

Exclusion Criteria:

History of xanthinuria
Alcohol consumption >14/week
History of significant concomitant illness
Active liver disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174941

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Chair:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Publications of Results:

Colwell HH, Hunt BJ, Pasta DJ, Palo WA, Mathias SD, Joseph-Ridge N. Gout Assessment Questionnaire: Initial results of reliability, validity and responsiveness. Int J Clin Pract. 2006 Oct;60(10):1210-7. Epub 2006 Aug 15.

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science )
Study ID Numbers:	TMX-01-005
Study First Received:	September 12, 2005
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00174941
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Uric acid
gout
xanthine oxidase
febuxostat
tophi

Study placed in the following topic categories:

Metabolism, Inborn Errors
Uric Acid
Metabolic Diseases
Genetic Diseases, Inborn
Musculoskeletal Diseases
Joint Diseases

Arthritis
Febuxostat
Rheumatic Diseases
Metabolic disorder
Purine-Pyrimidine Metabolism, Inborn Errors
Gout

Additional relevant MeSH terms:

Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009