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

Sponsor:	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

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.

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 Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). [ Time Frame: Last 3 visits (any last 3 visits up to week 28) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28 [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit [ Time Frame: Final Visit (up to 28 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 Final Visit [ Time Frame: Baseline and Final Visit (up to 28 weeks) ] [ Designated as safety issue: No ]
Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. [ Time Frame: Baseline and Week 28 ] [ Designated as safety issue: No ]
Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. [ Time Frame: Baseline and Final Visit (up to 28 weeks) ] [ Designated as safety issue: No ]
Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit. [ Time Frame: Baseline and Week 28 ] [ Designated as safety issue: No ]
Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit [ Time Frame: Final Visit (up to 28 weeks) ] [ Designated as safety issue: No ]
Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period. [ Time Frame: Weeks 8 through 28 ] [ 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, once daily for up to 28 weeks.
2: Experimental	Drug: Febuxostat Febuxostat 120 mg, orally, once daily for up to 28 weeks.
3: Experimental	Drug: Febuxostat Febuxostat 240 mg, orally, once daily for up to 28 weeks.
4: Active Comparator	Drug: Allopurinol Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
5: Placebo Comparator	Drug: Placebo Placebo, orally, once daily for up to 28 weeks.

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 (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association Criteria
Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 milliliters per minute (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 Director:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Additional Information:

Uloric Package Insert This link exits the ClinicalTrials.gov site

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

Publications:

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. ( Senior Vice President, Clinical Science )
Study ID Numbers:	C02-009
Study First Received:	September 9, 2005
Results First Received:	March 12, 2009
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00174915 History of Changes
Health Authority:	United States: Food and Drug Administration

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

Uric Acid, gout, xanthine oxidase, febuxostat, tophi

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 09, 2009