Phase 3
Completed N=504
Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Source: ClinicalTrials.gov NCT02082769 ↗Enrolled (actual)
504
Serious AEs
0.2%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL) — 22.5; 33.5; 17.0 percentage of participants
Summary
The purpose of this study is to compare febuxostat allopurinol in subjects with gout.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL) |
22.5; 33.5; 17.0 | — |
| SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit |
45.0; 58.9; 34.6 | — |
Eligibility Criteria
Inclusion Criteria
- Hyperuricemia (serum urate ≥8.0 mg/dL) and gout by Chinese Rheumatism Association Criteria;
- Renal function defined as a serum creatinine level of 20 milliliters per minute (mL/min) by Cockcroft and Gault formula;
- No gout flare 2 weeks beforehand during 2-week screening period.
Exclusion Criteria
- Pregnancy or lactation;
- Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;
- Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);
- A history of active liver disease, or hepatic dysfunction;
- A history of bronchial asthma;
- A history of renal calculi or thyroid disease;
- Secondary gout Joint diseases induced by rheumatoid arthritis, psoriatic arthritis and bone tumor;
- Intolerance to allopurinol and Ibuprofen;
- Alcohol intake of ≥ 14 drinks/week;
- Clinically significant medical condition.
Data sourced from ClinicalTrials.gov (NCT02082769). 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.