Phase 3
Completed N=1,086
Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010
Source: ClinicalTrials.gov NCT00175019 ↗Enrolled (actual)
1,086
Serious AEs
11.2%
Results posted
Sep 2009
Primary outcomePrimary: Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1. — 80.8; 87.0; 46.0 percentage of subjects
Summary
The purpose of this study is to determine the long-term safety of febuxostat, once daily (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1. |
80.8; 87.0; 46.0 | — |
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12. |
88.9; 86.3; 82.2 | — |
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24. |
89.3; 87.2; 78.6 | — |
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36. |
90.8; 91.5; 90.0 | — |
| PRIMARY Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment. |
70.8; 82.0; 32.6 | — |
| SECONDARY Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment. |
-46.69; -52.99; -32.17 | — |
| SECONDARY Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline. |
-82; -79; -56 | — |
| SECONDARY Percent Change From Baseline in Primary Tophus Size at Month 24 for Subjects With Palpable Tophi Measured at Baseline. |
-100; -96; -87 | — |
| SECONDARY Percent Change From Baseline in Primary Tophus Size at Month 36 for Subjects With Palpable Tophi Measured at Baseline. |
-83 | — |
| SECONDARY Percent Change From Baseline in Primary Tophus Size at Final Visit for Subjects With Palpable Tophi Measured at Baseline. |
-96; -84; -67 | — |
| SECONDARY Percent Change From Baseline in the Total Number of Tophi for Subjects With Palpable Tophi at Final Visit. |
-59.9; -58.3; -48.7 | — |
| SECONDARY Percentage of Subjects Requiring Treatment for Gout Flare up to Month 12. |
29.4; 42.5; 28.3 | — |
| SECONDARY Percentage of Subjects Requiring Treatment for Gout Flare After Month 12. |
15.3; 19.8; 23.2 | — |
Eligibility Criteria
Inclusion Criteria
- Is receiving thiazide diuretic therapy (only to subjects randomized to or receiving febuxostat).
- Has a serum urate level less than 8.0 mg/dL and is not taking uric acid-lowering therapy (other than allopurinol or febuxostat).
- Has participated in a clinical study in which febuxostat was administered.
- Is completing Phase 3 Studies C02-009 or C02-010.
- Must not have experienced any serious study drug-related adverse events in the previous study.
- 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
- Has had any other significant medical condition as defined by the investigator that would interfere with the treatment, safety, or compliance with the protocol.
- Is intolerant of allopurinol.
Data sourced from ClinicalTrials.gov (NCT00175019). 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.