Dose-Response, Safety and Efficacy of Febuxostat 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:	NCT00174967

Purpose

The purpose of this study is to determine the efficacy of febuxostat in reducing serum urate levels in subjects with gout.

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:

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit. [ Time Frame: Day 28. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit. [ Time Frame: Day 7. ] [ Designated as safety issue: No ]
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit. [ Time Frame: Day 14. ] [ Designated as safety issue: No ]
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit. [ Time Frame: Day 21. ] [ Designated as safety issue: No ]
Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit. [ Time Frame: Baseline and Day 7. ] [ Designated as safety issue: No ]
Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit. [ Time Frame: Baseline and Day 14. ] [ Designated as safety issue: No ]
Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit [ Time Frame: Baseline and Day 21. ] [ Designated as safety issue: No ]
Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit. [ Time Frame: Baseline and Day 28. ] [ Designated as safety issue: No ]
Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period. [ Time Frame: Baseline and Any visit (Day 7, 14, 21,or 28) ] [ Designated as safety issue: No ]
Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28. [ Time Frame: Baseline and 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 Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks.
2: Experimental	Drug: Febuxostat Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.
3: Experimental	Drug: Febuxostat Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.
4: Experimental	Drug: Febuxostat Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.

Detailed Description:

Gout is a chronic urate crystal deposition disorder, which if left untreated may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate concentration of >7.0 milligrams per deciliter (mg/dL), is the underlying metabolic aberration leading to urate crystal deposition in gout. Gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis. As serum urate levels increase beyond >7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.

Currently allopurinol is the only xanthine oxidase inhibitor available. Allopurinol is the agent of choice for reduction of serum urate levels in patients with: uric acid overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function; uric acid urolithiasis; or tophi.

Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

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 American College of Rheumatology criteria for gout.
Must have adequate renal function (serum creatinine <1.5 mg/dL).
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion Criteria:

History of xanthinuria
Alcohol consumption >14/week
Has a history of significant concomitant illness.
Has active liver disease.
Has a body mass index greater than 50 kilogram per meter² (kg/m²)
Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.

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

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:

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
Results First Received:	March 12, 2009
Last Updated:	August 13, 2009
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
xanthine oxidase
tophi
Drug Therapy

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 November 30, 2009