Phase 3
Completed N=2,269
Efficacy and Safety of Oral Febuxostat in Participants With Gout
Source: ClinicalTrials.gov NCT00430248 ↗Enrolled (actual)
2,269
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. — 45.2; 67.1; 42.1 percentage of subjects — p=0.233
Summary
The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. |
45.2; 67.1; 42.1 | 0.233 |
| SECONDARY Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl |
49.7; 71.6; 42.3 | 0.021 sig |
| SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit. |
49.1; 74.1; 43.2 | 0.031 sig |
| SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit. |
47.1; 75.2; 45.5 | 0.578 |
| SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit. |
48.9; 75.3; 46.6 | 0.426 |
| SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit. |
15.4; 45.9; 11.7 | 0.050 |
| SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit. |
15.0; 51.6; 13.5 | 0.428 |
| SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit. |
19.3; 49.7; 14.8 | 0.041 sig |
| SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit. |
16.5; 44.0; 13.2 | 0.083 |
| SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit |
2.1; 17.5; 1.5 | 0.421 |
| SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit |
2.0; 18.6; 1.4 | 0.520 |
| SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit |
3.1; 20.3; 1.8 | 0.195 |
| SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit |
2.5; 17.5; 1.5 | 0.196 |
| SECONDARY Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit. |
-35.1; -44.5; -33.8 | 0.079 |
| SECONDARY Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit |
-34.9; -45.5; -34.5 | 0.685 |
| SECONDARY Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit. |
-35.6; -45.1; -34.4 | 0.153 |
| SECONDARY Mean Percent Change From Baseline in Serum Urate Levels at Final Visit. |
-33.1; -40.6; -31.3 | 0.050 |
Eligibility Criteria
Inclusion Criteria
- Has one or more of the American Rheumatism Association criteria for the diagnosis of gout.
- 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.
- Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).
Exclusion Criteria
- Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study.
- Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation.
- History of xanthinuria.
- Alcohol consumption greater than 14/week.
- History of significant concomitant illness.
- Active liver or peptic ulcer disease.
- Has rheumatoid arthritis requiring treatment.
- Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight.
- Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.
Data sourced from ClinicalTrials.gov (NCT00430248). 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.