Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout
- Registration Number
- NCT00174967
- Lead Sponsor
- Takeda
- Brief Summary
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo QD Placebo - Febuxostat 120 mg QD Febuxostat - Febuxostat 40 mg QD Febuxostat - Febuxostat 80 mg QD Febuxostat -
- Primary Outcome Measures
Name Time Method Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit. Day 28. Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 28 visit was summarized.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit. Day 7. Serum urate values were obtained at the Day 7 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 7 visit was summarized.
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit. Day 14. Serum urate values were obtained at the Day 14 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 14 visit was summarized.
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit. Day 21. Serum urate values were obtained at the Day 21 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 21 visit was summarized.
Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit. Baseline and Day 7. Serum urate values were obtained at the Day 7 visit. The percent change in serum urate from baseline to the Day 7 visit was summarized.
Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit. Baseline and Day 14. Serum urate values were obtained at the Day 14 visit. The percent change in serum urate from baseline to the Day 14 visit was summarized.
Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit Baseline and Day 21. Serum urate values were obtained at the Day 21 visit. The percent change in serum urate from baseline to the Day 21 visit was summarized.
Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit. Baseline and Day 28. Serum urate values were obtained at the Day 28 visit. The percent change in serum urate from baseline to the Day 28 visit was summarized.
Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period. Baseline and Any visit (Day 7, 14, 21,or 28) Serum urate values were obtained at the Day 7, 14, 21,and 28 visits. The maximum percent change in serum urate levels obtained at any visit was summarized.
Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28. Baseline and Day 28. 24-hour urine uric acid levels were obtained at the Day 28 visit. The percent change in 24-hour urine uric acid level from baseline to the Day 28 visit was summarized.