Study of Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010 - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00175019

Purpose

To evaluate the long-term safety of febuxostat to reduce serum urate levels to in subjects with gout, as compared to allopurinol.

Condition	Intervention
Gout	Drug: Febuxostat Drug: Allopurinol

MedlinePlus related topics: Gout

Drug Information available for: Allopurinol Allopurinol sodium Tei 6720

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Open-Label, Randomized, Allopurinol-Controlled Study to Assess the Long-Term Safety 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 serum urate level decreases to < 6.0 mg/dL. [ Time Frame: At each visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent reduction in serum urate from baseline. [ Time Frame: At each vist ] [ Designated as safety issue: No ]
Percent reduction in primary tophus size for subjects with palpable tophi. [ Time Frame: At each visit ] [ Designated as safety issue: No ]
Reduction in the total number of tophi for subjects with palpable tophi. [ Time Frame: At each visit ] [ Designated as safety issue: No ]
Proportion of subjects requiring treatment for gout flare. [ Time Frame: At each visit ] [ Designated as safety issue: No ]

Enrollment:	1086
Study Start Date:	July 2003
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental The C02-021 Study was originally designed and initiated having all subjects initially assigned to 80 mg febuxostat provided as an 80 mg tablet, to be administered orally. Subjects could be titrated to 120 mg, provided as one 40 and 80 mg tablet, between Months 2 and 6, if their serum uric acid rose > 6.0 mg/dL; the dose could be down-titrated to 80 mg if the serum uric acid decreased to < 3.0 mg/dL. The protocol was amended to add a comparator arm, and to have subjects randomized to 80 or 120 mg febuxostat or allopurinol (100 or 300 mg, dependent on renal function). The information below reflects the treatments following the implementation of the revised protocol.	Drug: Febuxostat Febuxostat 80 mg in tablet form orally daily for up to 41 ;months.
2: Experimental	Drug: Febuxostat Febuxostat 120 mg in tablet form orally, daily for up to 41 months.
3: Active Comparator The C02-021 Study was originally designed and initiated having all subjects initially assigned to 80 mg febuxostat provided as an 80 mg tablet, to be administered orally. Subjects could be titrated to 120 mg, provided as one 40 and 80 mg tablet, between Months 2 and 6, if their serum uric acid rose > 6.0 mg/dL; the dose could be down-titrated to 80 mg if the serum uric acid decreased to < 3.0 mg/dL. The protocol was amended to add a comparator arm, and to have subjects randomized to 80 or 120 mg febuxostat or allopurinol (100 or 300 mg, dependent on renal function). The information below reflects the treatments following the implementation of the revised protocol.	Drug: Allopurinol Allopurinol, 100 or 300 mg in tablet form administered orally,dose titrated according to renal function for up to 41 months.

Detailed Description:

To evaluate the long-term safety of febuxostat 80 mg QD and 120 mg QD doses required to reduce serum urate levels to < 6.0 mg/dL in subjects with gout, as compared to allopurinol 100 or 300 mg depending on renal function.

Eligibility

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

Criteria

Inclusion Criteria:

Subjects completing Phase 3 Studies C02-009 or C02-010.

Exclusion Criteria:

Subject is breastfeeding or pregnant.
Subject has any other significant medical condition as defined by the investigator that would interfere with the treatment.
Subject is intolerant of allopurinol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175019

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Chair:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science )
Study ID Numbers:	C02-021
Study First Received:	September 12, 2005
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00175019
Health Authority:	United States: Food and Drug Administration

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

gout
uric acid
xanthine oxidase

hyperuricemia
febuxostat
tophi

Study placed in the following topic categories:

Allopurinol
Metabolic Diseases
Joint Diseases
Hyperuricemia
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