Phase 2
Completed N=153
Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout
Source: ClinicalTrials.gov NCT00174967 ↗Enrolled (actual)
153
Serious AEs
2.0%
Results posted
Jul 2009
Primary outcomePrimary: Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit. — 56; 76; 94; 0 percentage of subjects — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit. |
56; 76; 94; 0 | <0.001 sig |
| SECONDARY Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit. |
50; 59; 91; 3 | <0.001 sig |
| SECONDARY Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit. |
56; 68; 94; 0 | <0.001 sig |
| SECONDARY Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit. |
59; 76; 97; 0 | <0.001 sig |
| SECONDARY Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit. |
-35.0; -39.2; -53.44; 0.71 | <0.001 sig |
| SECONDARY Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit. |
-37.1; -41.8; -56.9; 1.62 | <0.001 sig |
| SECONDARY Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit |
-37.3; -43.9; -59.4; -0.57 | <0.001 sig |
| SECONDARY Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit. |
-36.6; -44.3; -59.1; -2.2 | <0.001 sig |
| SECONDARY Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period. |
42.5; 49.2; 62.8; 10.0 | <0.001 sig |
| SECONDARY Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28. |
-43.6; -46.5; -45.7; 5.9 | <0.001 sig |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT00174967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.