Dose-Response, Safety and Efficacy Study of Oral 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:	NCT00174967

Purpose

A Phase 2, dose response study of 40 mg, 80 mg and 120 mg/day of febuxostat or placebo for 4 weeks.

Condition	Intervention	Phase
Gout	Drug: Placebo Drug: Febuxostat	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II, Dose-Response, Safety and Efficacy Study of Oral TMX-67 in Subjects With Gout.

Resource links provided by NLM:

MedlinePlus related topics: Gout

Drug Information available for: Tei 6720

U.S. FDA Resources

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

Primary Outcome Measures:

Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL after treatment with study drug. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent reduction in serum urate levels from baseline to the end of the treatment period. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Enrollment:	153
Study Start Date:	January 2001
Study Completion Date:	July 2001
Primary Completion Date:	July 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo Placebo tablets orally daily for 4 weeks
2: Experimental	Drug: Febuxostat 40 mg in tablet form administered orally daily for 4 weeks
3: Experimental	Drug: Febuxostat 80 mg in tablet form administered orally daily for 4 weeks.
4: Experimental	Drug: Febuxostat 120 mg administered orally in tablet form daily for 4 weeks.

Detailed Description:

This is a phase two, randomized, double-blind, placebo controlled, multi-center dose response trial designed to determine the oral dose(s) of febuxostat which safely and effectively reduce serum urate levels.

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),
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: NCT00174967

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Chair:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Publications:

Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Palo WA, Eustace D, Vernillet L, Joseph-Ridge N. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twenty-eight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum. 2005 Mar;52(3):916-23.

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-00-004
Study First Received:	September 9, 2005
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00174967 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

Study placed in the following topic categories:

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

Uric Acid
Musculoskeletal Diseases
Genetic Diseases, Inborn
Arthritis
Antirheumatic Agents
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Joint Diseases
Febuxostat
Rheumatic Diseases
Gout Suppressants
Pharmacologic Actions
Gout

Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Musculoskeletal Diseases
Genetic Diseases, Inborn
Arthritis
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 02, 2009