Trial | NCT02082769  Report issue

Title

Safety and Efficacy of Oral Febuxostat in Subjects With Gout
A Phase 3, Randomized, Multicenter, Allopurinol-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Indication/Condition

    Gout

  • Study Participants

    504
The purpose of this study is to compare febuxostat allopurinol in subjects with gout.
A randomized, double-blind, multicenter, allopurinol-controlled and parallel-assigned study comparing 40 mg, 80 mg of febuxostat, and allopurinol 300 mg in subjects with gout. Subjects will receive treatment for 24 weeks.
Study Started
Jul 31
2011
Primary Completion
Oct 31
2013
Study Completion
Oct 31
2013
Results Posted
Feb 03
2016
Estimate
Last Update
Feb 03
2016
Estimate

Drug Febuxostat

Drug Allopurinol

Febuxostat 40 mg QD Experimental

Febuxostat 40 mg, orally, once daily for up to 24 weeks

Febuxostat 80 mg QD Experimental

Febuxostat 80 mg, orally, once daily for up to 24 weeks

Allopurinol 100mg QD Active Comparator

Allopurinol 100mg, orally, three times daily for up to 24 weeks

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 < 2.0 mg/dL and creatinine clearance 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.

Summary

Febuxostat 40 mg QD

Febuxostat 80 mg QD

Allopurinol 100mg QD

All Events

Event Type Organ System Event Term Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 100mg QD

Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)

Febuxostat 40 mg QD

22.5
percentage of participants

Febuxostat 80 mg QD

33.5
percentage of participants

Allopurinol 100mg QD

17.0
percentage of participants

Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit

Febuxostat 40 mg QD

45.0
percentage of participants

Febuxostat 80 mg QD

58.9
percentage of participants

Allopurinol 100mg QD

34.6
percentage of participants

Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline

Febuxostat 40 mg QD

182.2
umol/l (Mean)
Standard Deviation: 115.6

Febuxostat 80 mg QD

216.0
umol/l (Mean)
Standard Deviation: 137.2

Allopurinol 100mg QD

170.4
umol/l (Mean)
Standard Deviation: 132.6

Total

477
Participants

Age, Continuous

46.7
years (Mean)
Standard Deviation: 11.2

Baseline serum urate level units

566.7
umol/l (Mean)
Standard Deviation: 75.2

Body Mass Index (BMI)

25.2
kg/m^2 (Mean)
Standard Deviation: 2.8

Diastolic blood pressure (DBP)

78.5
mm Hg (Mean)
Standard Deviation: 8.1

Systolic blood pressure (SBP)

126.4
mm Hg (Mean)
Standard Deviation: 10.4

Age, Categorical

Sex: Female, Male

Overall Study

Febuxostat 40 mg QD

Febuxostat 80 mg QD

Allopurinol 100mg QD