Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects. - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00174915

Purpose

A Study comparing febuxostat, allopurinol and placebo in subjects with gout.

Condition	Intervention	Phase
Gout	Drug: Febuxostat Drug: Allopurinol Drug: Placebo	Phase III

MedlinePlus related topics: Gout

Drug Information available for: Allopurinol Allopurinol sodium Tei 6720 BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Randomized, Multicenter, Allopurinol and Placebo-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout.

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

Primary Outcome Measures:

The proportion of subjects whose last three serum urate levels are < 6.0 mg/dL. [ Time Frame: Weeks 2,4,8,12,16,20,24,and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of subjects whose serum urate levels are <6.0 mg/dL; [ Time Frame: Week 28 and Final Visit ] [ Designated as safety issue: No ]
The percent reduction in serum urate levels; [ Time Frame: Week 28 and Final Visit ] [ Designated as safety issue: No ]
The percent reduction in primary tophus size, as determined by physical measurement in the subset of subjects with palpable tophi at the Screening Visit.; [ Time Frame: Week 28 and Final Visit ] [ Designated as safety issue: No ]
The reduction in the total number of tophi in the subset of subjects with palpable tophi at the Screening Visit; [ Time Frame: Week 28 and Final Visit ] [ Designated as safety issue: No ]
The proportion of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the Double-Blind Treatment Period. [ Time Frame: Weeks 8-28 in 4 week intervals ] [ Designated as safety issue: No ]

Enrollment:	1072
Study Start Date:	February 2003
Study Completion Date:	April 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Febuxostat Febuxostat 80 mg orally daily, provided as 2 small placebo tablets, 1 large febuxostat 80 mg tablet and 1 placebo tablet to match and 1 placebo capsule to match.
2: Experimental	Drug: Febuxostat Febuxostat 120 mg, orally once daily, provided as 1 small 40 mg tablet and placebo to match, 1 large 80 mg febuxostat tablet and placebo to match and 1 placebo capsule to match.
3: Experimental	Drug: Febuxostat Febuxostat 240 mg,orally daily, provided as 2 small 40 mg tablets, 2 large 80 mg febuxostat tablets, and 1 placebo capsule to match.
4: Active Comparator	Drug: Allopurinol Allopurinol, 100 mg or 300 mg orally, daily, depending on baseline renal function, provided as 2 small placebo tablets, 2 large placebo tablets, and either one 100 or 300 mg allopurinol capsule.
5: Placebo Comparator	Drug: Placebo Placebo, orally, daily, provided as 2 small tablets, 2 large tablets and 1 placebo capsule to match.

Detailed Description:

A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for those with normal renal function and 100 mg for those with impaired renal function) and placebo administered once daily in subjects with gout.

Subjects will receive treatment for 28 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Hyperuricemia (sUA ≥8.0mg/dL) and gout by ARA Criteria
Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 mL/min by Cockroft and Gault formula.

Exclusion Criteria:

History of xanthinuria
Intolerance to allopurinol
Presence of renal calculi,
Alcohol intake of ≥ 14 drinks/week
Clinically significant medical condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174915

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Chair:

Medical Director

TAP Pharmaceutical Products Inc.

More Information

Publications of Results:

Schumacher HR Jr, Becker MA, Wortmann RL, Macdonald PA, Hunt B, Streit J, Lademacher C, Joseph-Ridge N. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: A 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008 Nov 15;59(11):1540-8.

Becker MA, MacDonald PA, Hunt BJ, Lademacher C, Joseph-Ridge N. Determinants of the clinical outcomes of gout during the first year of urate-lowering therapy. Nucleosides Nucleotides Nucleic Acids. 2008 Jun;27(6):585-91.

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences )
Study ID Numbers:	C02-009
Study First Received:	September 9, 2005
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00174915
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:

Allopurinol
Metabolic Diseases
Joint Diseases
Febuxostat
Rheumatic Diseases
Gout
Purine-Pyrimidine Metabolism, Inborn Errors

Metabolism, Inborn Errors
Uric Acid
Musculoskeletal Diseases
Genetic Diseases, Inborn
Arthritis
Metabolic disorder

Additional relevant MeSH terms:

Antimetabolites
Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Free Radical Scavengers

Enzyme Inhibitors
Antirheumatic Agents
Protective Agents
Gout Suppressants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009