CompletedNCT00174967Updated Jul 29, 2011Results posted

Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout

A Phase 2 interventional study of Placebo and Febuxostat in Gout, sponsored by Takeda. Completed. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-07-29.

Sponsored by Takeda · Phase 2, Interventional, and Diagnostic

Phase: Phase 2
Study type: Interventional
Enrollment: 153
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study summary

The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.

Read the detailed description

Gout is a chronic urate crystal deposition disorder, which if left untreated may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate concentration of >7.0 milligrams per deciliter (mg/dL), is the underlying metabolic aberration leading to urate crystal deposition in gout. Gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis. As serum urate levels increase beyond >7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.

Currently allopurinol is the only xanthine oxidase inhibitor available. Allopurinol is the agent of choice for reduction of serum urate levels in patients with: uric acid overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function; uric acid urolithiasis; or tophi.

Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

Conditions studied

Gout

Browse trials for

Gout 232

Keywords

Uric Acid
xanthine oxidase
tophi
Drug Therapy

In context

Gout

232 studies on the registry are indexed under Gout; 45 are open to participants now.

This study's enrollment of 153 is above the median of 121 across 202 interventional studies indexed under Gout.

Browse Gout studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Hyperuricemia (serum uric acid ≥8.0 mg/dL).
Must meet American College of Rheumatology criteria for gout.
Must have adequate renal function (serum creatinine \<1.5 mg/dL).
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

Exclusion Criteria:

History of xanthinuria
Alcohol consumption >14/week
Has a history of significant concomitant illness.
Has active liver disease.
Has a body mass index greater than 50 kilogram per meter² (kg/m²)
Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.

Study design

Phase: Phase 2
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 153 participants (actual)

Study arms

Placebo comparator
Placebo QD
Drug: Placebo
Experimental
Febuxostat 40 mg QD
Drug: Febuxostat
Experimental
Febuxostat 80 mg QD
Drug: Febuxostat
Experimental
Febuxostat 120 mg QD
Drug: Febuxostat

Interventions

DrugPlacebo
Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks.
DrugFebuxostat
Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.
Also known as: TMX-67, Tei-6720, Uloric
DrugFebuxostat
Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.
Also known as: TMX-67, Tei-6720, Uloric
DrugFebuxostat
Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.
Also known as: TMX-67, Tei-6720, Uloric

What researchers measure

Primary outcomes

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.
Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 28 visit was summarized.
Time frame: Day 28.

Secondary outcomes

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.
Serum urate values were obtained at the Day 7 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 7 visit was summarized.
Time frame: Day 7.
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.
Serum urate values were obtained at the Day 14 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 14 visit was summarized.
Time frame: Day 14.
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.
Serum urate values were obtained at the Day 21 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 21 visit was summarized.
Time frame: Day 21.
Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.
Serum urate values were obtained at the Day 7 visit. The percent change in serum urate from baseline to the Day 7 visit was summarized.
Time frame: Baseline and Day 7.
Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.
Serum urate values were obtained at the Day 14 visit. The percent change in serum urate from baseline to the Day 14 visit was summarized.
Time frame: Baseline and Day 14.
Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit
Serum urate values were obtained at the Day 21 visit. The percent change in serum urate from baseline to the Day 21 visit was summarized.
Time frame: Baseline and Day 21.
Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.
Serum urate values were obtained at the Day 28 visit. The percent change in serum urate from baseline to the Day 28 visit was summarized.
Time frame: Baseline and Day 28.
Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.
Serum urate values were obtained at the Day 7, 14, 21,and 28 visits. The maximum percent change in serum urate levels obtained at any visit was summarized.
Time frame: Baseline and Any visit (Day 7, 14, 21,or 28)
Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.
24-hour urine uric acid levels were obtained at the Day 28 visit. The percent change in 24-hour urine uric acid level from baseline to the Day 28 visit was summarized.
Time frame: Baseline and Day 28.

Results

Posted Jul 16, 2009

Participant flow

Subjects were enrolled at 24 investigative sites from 31 January 2001 to 9 July 2001

Participant flow — Overall Study
Milestone	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
Started	37	40	38	38
Completed	36	37	36	36
Not completed	1	3	2	2
Withdrew: Adverse event	1	2	2	1
Withdrew: Gout flare	0	0	0	1
Withdrew: Other	0	1	0	0

Outcome measures

PrimaryPercentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.

Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 28 visit was summarized.

Time frame:: Day 28.
Reported as:: Number · percentage of subjects

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.
percentage of subjects	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.	56	76	94	0

Statistical analysis

Febuxostat 40 mg QD vs Placebo QD · Fisher Exact · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 80 mg QD vs Placebo QD · Fisher Exact · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 120 mg QD vs Placebo QD · Fisher Exact · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.)

SecondaryPercentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.

Serum urate values were obtained at the Day 7 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 7 visit was summarized.

Time frame:: Day 7.
Reported as:: Number · percentage of subjects

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.
percentage of subjects	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.	50	59	91	3

Statistical analysis

Febuxostat 40 mg QD vs Placebo QD · Fisher Exact · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 80 mg QD vs Placebo QD · Fisher Exact · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 120 mg QD vs Placebo QD · Fisher Exact · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.)

SecondaryPercentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.

Serum urate values were obtained at the Day 14 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 14 visit was summarized.

Time frame:: Day 14.
Reported as:: Number · percentage of subjects

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.
percentage of subjects	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.	56	68	94	0

Statistical analysis

Febuxostat 40 mg QD vs Placebo QD · Fisher Exact · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 80 mg QD vs Placebo QD · Fisher Exact · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 120 mg QD vs Placebo QD · Fisher Exact · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.)

SecondaryPercentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.

Serum urate values were obtained at the Day 21 visit. The percentage of subjects whose serum urate decreased to \<6.0 mg/dL at the Day 21 visit was summarized.

Time frame:: Day 21.
Reported as:: Number · percentage of subjects

Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.
percentage of subjects	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.	59	76	97	0

Statistical analysis

Febuxostat 40 mg QD vs Placebo QD · Fisher Exact · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 80 mg QD vs Placebo QD · Fisher Exact · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 120 mg QD vs Placebo QD · Fisher Exact · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.)

SecondaryPercent Change in Serum Urate Levels From Baseline to the Day 7 Visit.

Serum urate values were obtained at the Day 7 visit. The percent change in serum urate from baseline to the Day 7 visit was summarized.

Time frame:: Baseline and Day 7.
Reported as:: Mean · percent change from baseline

Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.
percent change from baseline	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.	-35.0 ± 9.67	-39.2 ± 15.9	-53.44 ± 12.3	0.71 ± 12.6

Statistical analysis

Febuxostat 40 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 80 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 120 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)

SecondaryPercent Change in Serum Urate Levels From Baseline to the Day 14 Visit.

Serum urate values were obtained at the Day 14 visit. The percent change in serum urate from baseline to the Day 14 visit was summarized.

Time frame:: Baseline and Day 14.
Reported as:: Mean · percent change from baseline

Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.
percent change from baseline	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.	-37.1 ± 11.70	-41.8 ± 14.63	-56.9 ± 8.36	1.62 ± 10.21

Statistical analysis

Febuxostat 40 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 80 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 120 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)

SecondaryPercent Change in Serum Urate Levels From Baseline to the Day 21 Visit

Serum urate values were obtained at the Day 21 visit. The percent change in serum urate from baseline to the Day 21 visit was summarized.

Time frame:: Baseline and Day 21.
Reported as:: Mean · percent change from baseline

Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit
percent change from baseline	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit	-37.3 ± 11.30	-43.9 ± 16.3	-59.4 ± 7.58	-0.57 ± 10.63

Statistical analysis

Febuxostat 40 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 80 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 120 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)

SecondaryPercent Change in Serum Urate Levels From Baseline to the Day 28 Visit.

Serum urate values were obtained at the Day 28 visit. The percent change in serum urate from baseline to the Day 28 visit was summarized.

Time frame:: Baseline and Day 28.
Reported as:: Mean · percent change from baseline

Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.
percent change from baseline	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.	-36.6 ± 12.07	-44.3 ± 17.53	-59.1 ± 9.92	-2.2 ± 12.5

Statistical analysis

Febuxostat 40 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 80 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 120 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)

SecondaryMaximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.

Serum urate values were obtained at the Day 7, 14, 21,and 28 visits. The maximum percent change in serum urate levels obtained at any visit was summarized.

Time frame:: Baseline and Any visit (Day 7, 14, 21,or 28)
Reported as:: Mean · percent change from baseline

Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.
percent change from baseline	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.	42.5 ± 10.04	49.2 ± 13.24	62.8 ± 7.05	10.0 ± 11.12

Statistical analysis

Febuxostat 40 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 80 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 120 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)

SecondaryPercent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.

24-hour urine uric acid levels were obtained at the Day 28 visit. The percent change in 24-hour urine uric acid level from baseline to the Day 28 visit was summarized.

Time frame:: Baseline and Day 28.
Reported as:: Mean · percent change from baseline

Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.
percent change from baseline	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.	-43.6 ± 28.9	-46.5 ± 27.0	-45.7 ± 30.1	5.9 ± 37.1

Statistical analysis

Febuxostat 40 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 80 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)
Febuxostat 120 mg QD vs Placebo QD · t-test, 2 sided · p = <0.001 (Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Febuxostat 40 mg QD	—	0/37 (0%)	18/37 (48.6%)
Febuxostat 80 mg QD	—	1/40 (2.5%)	19/40 (47.5%)
Febuxostat 120 mg QD	—	2/38 (5.3%)	16/38 (42.1%)
Placebo QD	—	0/38 (0%)	17/38 (44.7%)

Most frequent serious events

Most frequent serious events
Event	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
Suicide AttemptPsychiatric disorders	0/37	0/40	1/38	0/38
Back PainGeneral disorders	0/37	0/40	1/38	0/38
DeliriumNervous system disorders	0/37	1/40	0/38	0/38
Guillian Barre SyndromeNervous system disorders	0/37	1/40	0/38	0/38
PneumoniaRespiratory, thoracic and mediastinal disorders	0/37	1/40	0/38	0/38

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD
DiarrhoeaGastrointestinal disorders	1/37	8/40	4/38	4/38
PainGeneral disorders	6/37	3/40	2/38	4/38
Back PainGeneral disorders	3/37	2/40	2/38	1/38
HeadacheNervous system disorders	3/37	2/40	2/38	1/38
Abdominal PainGeneral disorders	1/37	1/40	2/38	3/38
RashSkin and subcutaneous tissue disorders	0/37	1/40	3/38	0/38
Increased AppetiteGastrointestinal disorders	2/37	0/40	0/38	0/38
Liver Function Tests AbnormalInvestigations	2/37	1/40	1/38	1/38
ArthralgiaMusculoskeletal and connective tissue disorders	2/37	1/40	2/38	0/38
Flu SyndromeGeneral disorders	1/37	0/40	1/38	2/38

Baseline characteristics

Age Continuous
Age Continuous(years)	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD	Total
Mean	52.2 ± 14.04	55.2 ± 13.09	56.2 ± 10.83	52.4 ± 12.63	54.0 ± 12.69

Age, Customized
Age, Customized(participants)	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD	Total
<45 years	8	10	7	12	37
45 years to <65 years	21	19	23	17	80
≥65 years	8	11	8	9	36

Sex: Female, Male
Sex: Female, Male(Participants)	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD	Total
Female	4	2	5	6	17
Male	33	38	33	32	136

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD	Total
White	32	35	34	32	133
Black or African American	3	3	2	3	11
Hispanic	1	1	1	1	4
Asian	0	1	1	0	2
Other	1	0	0	2	3

Body Mass Index
Body Mass Index(participants)	Febuxostat 40 mg QD	Febuxostat 80 mg QD	Febuxostat 120 mg QD	Placebo QD	Total
≤25 kilogram per meter² (kg/m²)	2	3	3	0	8
>25 kg/m² to 30 kg/m²	12	12	14	13	51
>30 kg/m² to 35 kg/m²	16	12	12	16	56
>35 kg/m² to 40 kg/m²	4	7	5	6	22
>40 kg/m²	3	6	3	3	15
missing	0	0	1	0	1

Study locations

No study locations are listed for this record.

References and documents

Publications

Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Palo WA, Eustace D, Vernillet L, Joseph-Ridge N. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twenty-eight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum. 2005 Mar;52(3):916-23. doi: 10.1002/art.20935. PubMed 15751090 ↗
Colwell HH, Hunt BJ, Pasta DJ, Palo WA, Mathias SD, Joseph-Ridge N. Gout Assessment Questionnaire: Initial results of reliability, validity and responsiveness. Int J Clin Pract. 2006 Oct;60(10):1210-7. doi: 10.1111/j.1742-1241.2006.01104.x. Epub 2006 Aug 15. PubMed 16911575 ↗
Goldfarb DS, MacDonald PA, Hunt B, Gunawardhana L. Febuxostat in gout: serum urate response in uric acid overproducers and underexcretors. J Rheumatol. 2011 Jul;38(7):1385-9. doi: 10.3899/jrheum.101156. Epub 2011 May 15. PubMed 21572152 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00174967
Lead sponsor: Takeda
First posted: Sep 15, 2005
Start date: Jan 2001
Primary completion: Jul 2001
Completion: Jul 2001
Results posted: Jul 16, 2009
Last update: Jul 29, 2011

Study contacts

Medical Director

study chair · Takeda

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout

Study summary

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