Febuxostat Versus Allopurinol Control Trial in Subjects With Gout - Full Text View

Sponsor:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00102440

Purpose

The purpose of this study is to evaluate the safety and efficacy of febuxostat versus allopurinol in subjects with gout.

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

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 Study Comparing the Safety and Efficacy of Oral Febuxostat Versus Allopurinol in Subjects With Gout

Resource links provided by NLM:

MedlinePlus related topics: Gout

Drug Information available for: Allopurinol sodium Tei 6720 Allopurinol

U.S. FDA Resources

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

Primary Outcome Measures:

Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL) [ Time Frame: Last 3 Visits (up to 52 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit [ Time Frame: Final Visit (up to 52 weeks) ] [ Designated as safety issue: No ]
Percent Change From Baseline in Serum Urate Levels at Week 28. [ Time Frame: Baseline and Week 28 ] [ Designated as safety issue: No ]
Percent Change From Baseline in Serum Urate Levels at Week 52. [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Percent Change From Baseline in Serum Urate Levels at Final Visit [ Time Frame: Baseline and Final Visit (up to 52 weeks) ] [ Designated as safety issue: No ]
Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. [ Time Frame: Baseline and Week 28 ] [ Designated as safety issue: No ]
Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. [ Time Frame: Baseline and Final Visit (up to 52 weeks) ] [ Designated as safety issue: No ]
Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening. [ Time Frame: Baseline and Week 28 ] [ Designated as safety issue: No ]
Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening. [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening. [ Time Frame: Baseline and Final Visit (up to 52 weeks) ] [ Designated as safety issue: No ]
Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52. [ Time Frame: Weeks 8 through 52 ] [ Designated as safety issue: No ]

Enrollment:	760
Study Start Date:	July 2002
Study Completion Date:	February 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Febuxostat Febuxostat 80 mg, orally, once daily for up to 52 weeks.
2: Experimental	Drug: Febuxostat Febuxostat 120 mg, orally, once daily for up to 52 weeks.
3: Active Comparator	Drug: Allopurinol Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.

Detailed Description:

This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization. Subjects were then randomized to one of three treatment groups: febuxostat 80 milligram (mg), febuxostat 120 mg, or allopurinol 300 mg. Naproxen (250 mg twice daily) or colchicine (0.6 mg once daily) was provided for prophylaxis of acute gout flares during the washout period and the first 8 weeks of double-blind treatment.

Eligibility

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

Criteria

Inclusion Criteria:

Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline

Exclusion Criteria:

Serum creatinine >1.5 mg/dL
Calculated creatinine clearance of <50 milliliters per minutes (mL/min)
Pregnancy or lactation;
Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;
Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);
A history of xanthinuria, active liver disease, or hepatic dysfunction;
A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102440

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Additional Information:

American College of Rheumatology This link exits the ClinicalTrials.gov site

Uloric Package Insert This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

Publications:

Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Eustace D, Palo WA, Streit J, Joseph-Ridge N. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005 Dec 8;353(23):2450-61.

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 Science )
Study ID Numbers:	C02-010
Study First Received:	January 29, 2005
Results First Received:	March 12, 2009
Last Updated:	August 17, 2009
ClinicalTrials.gov Identifier:	NCT00102440 History of Changes
Health Authority:	United States: Food and Drug Administration

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

uric Acid
xanthine oxidase
tophi
Drug Therapy

Additional relevant MeSH terms:

Antimetabolites
Allopurinol
Antioxidants
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Joint Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Febuxostat
Rheumatic Diseases
Protective Agents

Gout Suppressants
Pharmacologic Actions
Gout
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Musculoskeletal Diseases
Genetic Diseases, Inborn
Therapeutic Uses
Arthritis
Free Radical Scavengers
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 05, 2009