Dose-Response, Safety and Efficacy Study of Oral Febuxostat in Subjects With Gout - Full Text View

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

MedlinePlus related topics:

Gout

ChemIDplus related topics:

Tei 6720

U.S. FDA Resources

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.

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 of Results:

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.

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences )
Study ID Numbers:	TMX-00-004
First Received:	September 9, 2005
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00174967
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:

Metabolism, Inborn Errors

Uric Acid

Metabolic Diseases

Genetic Diseases, Inborn

Musculoskeletal Diseases

Joint Diseases

Arthritis

Febuxostat

Rheumatic Diseases

Metabolic disorder

Purine-Pyrimidine Metabolism, Inborn Errors

Gout

Additional relevant MeSH terms:

Therapeutic Uses

Antirheumatic Agents

Gout Suppressants

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00174967