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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02082769
Enrollment
504
Registered
2014-03-10
Start date
2011-07-31
Completion date
2013-10-31
Last updated
2016-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Keywords

Gout, Uric Acid, Xanthine oxidase, Febuxostat

Brief summary

The purpose of this study is to compare febuxostat allopurinol in subjects with gout.

Detailed description

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.

Interventions

DRUGAllopurinol
DRUGFebuxostat

Sponsors

Qingdao Shengbang Pharmaceutical Co., Ltd.
CollaboratorINDUSTRY
Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)Last 3 visits (any last 3 visits up to week 26)

Secondary

MeasureTime frame
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final VisitFinal Visit (up to 26 weeks)

Other

MeasureTime frame
Absolute Change in the Serum Urate Level at the Final Visit Relative to BaselineBaseline and Final Visit (up to 26 weeks)

Participant flow

Participants by arm

ArmCount
Febuxostat 40 mg QD
Febuxostat 40 mg, orally, once daily for up to 24 weeks Febuxostat
160
Febuxostat 80 mg QD
Febuxostat 80 mg, orally, once daily for up to 24 weeks Febuxostat
158
Allopurinol 100mg QD
Allopurinol 100mg, orally, three times daily for up to 24 weeks Allopurinol
159
Total477

Baseline characteristics

CharacteristicFebuxostat 40 mg QDFebuxostat 80 mg QDAllopurinol 100mg QDTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
160 Participants158 Participants159 Participants477 Participants
Age, Continuous45.5 years
STANDARD_DEVIATION 11.9
48.2 years
STANDARD_DEVIATION 12
46.5 years
STANDARD_DEVIATION 10.7
46.7 years
STANDARD_DEVIATION 11.2
Baseline serum urate level units560.8 umol/l
STANDARD_DEVIATION 73.3
565.1 umol/l
STANDARD_DEVIATION 75.5
574.2 umol/l
STANDARD_DEVIATION 77.8
566.7 umol/l
STANDARD_DEVIATION 75.2
Body Mass Index (BMI)25.2 kg/m^2
STANDARD_DEVIATION 2.7
25.1 kg/m^2
STANDARD_DEVIATION 2.6
25.4 kg/m^2
STANDARD_DEVIATION 3.3
25.2 kg/m^2
STANDARD_DEVIATION 2.8
Diastolic blood pressure (DBP)79.1 mm Hg
STANDARD_DEVIATION 8.2
77.6 mm Hg
STANDARD_DEVIATION 8.1
78.7 mm Hg
STANDARD_DEVIATION 7.9
78.5 mm Hg
STANDARD_DEVIATION 8.1
Sex: Female, Male
Female
158 Participants146 Participants149 Participants453 Participants
Sex: Female, Male
Male
2 Participants12 Participants10 Participants24 Participants
Systolic blood pressure (SBP)126.2 mm Hg
STANDARD_DEVIATION 10
126.4 mm Hg
STANDARD_DEVIATION 11
124.8 mm Hg
STANDARD_DEVIATION 10.1
126.4 mm Hg
STANDARD_DEVIATION 10.4

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
45 / 16846 / 16841 / 168
serious
Total, serious adverse events
0 / 1681 / 1680 / 168

Outcome results

Primary

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

Time frame: Last 3 visits (any last 3 visits up to week 26)

ArmMeasureValue (NUMBER)
Febuxostat 40 mg QDPercentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)22.5 percentage of participants
Febuxostat 80 mg QDPercentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)33.5 percentage of participants
Allopurinol 100mg QDPercentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)17.0 percentage of participants
Secondary

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

Time frame: Final Visit (up to 26 weeks)

ArmMeasureValue (NUMBER)
Febuxostat 40 mg QDPercentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit45.0 percentage of participants
Febuxostat 80 mg QDPercentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit58.9 percentage of participants
Allopurinol 100mg QDPercentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit34.6 percentage of participants
Other Pre-specified

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

Time frame: Baseline and Final Visit (up to 26 weeks)

ArmMeasureValue (MEAN)Dispersion
Febuxostat 40 mg QDAbsolute Change in the Serum Urate Level at the Final Visit Relative to Baseline182.2 umol/lStandard Deviation 115.6
Febuxostat 80 mg QDAbsolute Change in the Serum Urate Level at the Final Visit Relative to Baseline216.0 umol/lStandard Deviation 137.2
Allopurinol 100mg QDAbsolute Change in the Serum Urate Level at the Final Visit Relative to Baseline170.4 umol/lStandard Deviation 132.6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026