Trial Outcomes & Findings for Safety and Efficacy of Oral Febuxostat in Subjects With Gout (NCT NCT02082769)
NCT ID: NCT02082769
Last Updated: 2016-02-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
504 participants
Primary outcome timeframe
Last 3 visits (any last 3 visits up to week 26)
Results posted on
2016-02-03
Participant Flow
Participant milestones
| Measure |
Febuxostat 40 mg QD
Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Febuxostat 80 mg QD
Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Allopurinol 100mg QD
Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol
|
|---|---|---|---|
|
Overall Study
STARTED
|
168
|
168
|
168
|
|
Overall Study
COMPLETED
|
144
|
141
|
132
|
|
Overall Study
NOT COMPLETED
|
24
|
27
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Baseline characteristics by cohort
| Measure |
Febuxostat 40 mg QD
n=160 Participants
Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Febuxostat 80 mg QD
n=158 Participants
Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Allopurinol 100mg QD
n=159 Participants
Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol
|
Total
n=477 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
160 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
477 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
453 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
25.2 kg/m^2
STANDARD_DEVIATION 2.7 • n=5 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 2.6 • n=7 Participants
|
25.4 kg/m^2
STANDARD_DEVIATION 3.3 • n=5 Participants
|
25.2 kg/m^2
STANDARD_DEVIATION 2.8 • n=4 Participants
|
|
Systolic blood pressure (SBP)
|
126.2 mm Hg
STANDARD_DEVIATION 10.0 • n=5 Participants
|
126.4 mm Hg
STANDARD_DEVIATION 11.0 • n=7 Participants
|
124.8 mm Hg
STANDARD_DEVIATION 10.1 • n=5 Participants
|
126.4 mm Hg
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Diastolic blood pressure (DBP)
|
79.1 mm Hg
STANDARD_DEVIATION 8.2 • n=5 Participants
|
77.6 mm Hg
STANDARD_DEVIATION 8.1 • n=7 Participants
|
78.7 mm Hg
STANDARD_DEVIATION 7.9 • n=5 Participants
|
78.5 mm Hg
STANDARD_DEVIATION 8.1 • n=4 Participants
|
|
Baseline serum urate level units
|
560.8 umol/l
STANDARD_DEVIATION 73.3 • n=5 Participants
|
565.1 umol/l
STANDARD_DEVIATION 75.5 • n=7 Participants
|
574.2 umol/l
STANDARD_DEVIATION 77.8 • n=5 Participants
|
566.7 umol/l
STANDARD_DEVIATION 75.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: Last 3 visits (any last 3 visits up to week 26)Outcome measures
| Measure |
Febuxostat 40 mg QD
n=160 Participants
Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Febuxostat 80 mg QD
n=158 Participants
Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Allopurinol 100mg QD
n=159 Participants
Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol
|
|---|---|---|---|
|
Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)
|
22.5 percentage of participants
|
33.5 percentage of participants
|
17.0 percentage of participants
|
SECONDARY outcome
Timeframe: Final Visit (up to 26 weeks)Outcome measures
| Measure |
Febuxostat 40 mg QD
n=160 Participants
Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Febuxostat 80 mg QD
n=158 Participants
Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Allopurinol 100mg QD
n=159 Participants
Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol
|
|---|---|---|---|
|
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit
|
45.0 percentage of participants
|
58.9 percentage of participants
|
34.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Final Visit (up to 26 weeks)Outcome measures
| Measure |
Febuxostat 40 mg QD
n=160 Participants
Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Febuxostat 80 mg QD
n=158 Participants
Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Allopurinol 100mg QD
n=159 Participants
Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol
|
|---|---|---|---|
|
Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline
|
182.2 umol/l
Standard Deviation 115.6
|
216.0 umol/l
Standard Deviation 137.2
|
170.4 umol/l
Standard Deviation 132.6
|
Adverse Events
Febuxostat 40 mg QD
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Febuxostat 80 mg QD
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Allopurinol 100mg QD
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Febuxostat 40 mg QD
n=168 participants at risk
Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Febuxostat 80 mg QD
n=168 participants at risk
Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Allopurinol 100mg QD
n=168 participants at risk
Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol
|
|---|---|---|---|
|
Renal and urinary disorders
hydronephrosis
|
0.00%
0/168
|
0.60%
1/168 • Number of events 1
|
0.00%
0/168
|
Other adverse events
| Measure |
Febuxostat 40 mg QD
n=168 participants at risk
Febuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Febuxostat 80 mg QD
n=168 participants at risk
Febuxostat 80 mg, orally, once daily for up to 24 weeks
Febuxostat
|
Allopurinol 100mg QD
n=168 participants at risk
Allopurinol 100mg, orally, three times daily for up to 24 weeks
Allopurinol
|
|---|---|---|---|
|
Hepatobiliary disorders
Liver function test abnormalities
|
10.1%
17/168 • Number of events 17
|
13.1%
22/168 • Number of events 22
|
10.7%
18/168 • Number of events 18
|
|
Renal and urinary disorders
Renal function test abnormalities
|
1.2%
2/168 • Number of events 2
|
4.2%
7/168 • Number of events 7
|
1.2%
2/168 • Number of events 2
|
|
Cardiac disorders
Abnormal electrocardiogram
|
2.4%
4/168 • Number of events 4
|
0.00%
0/168
|
0.60%
1/168 • Number of events 1
|
|
Renal and urinary disorders
Abnormal urine protein
|
2.4%
4/168 • Number of events 4
|
2.4%
4/168 • Number of events 4
|
0.60%
1/168 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Drug allergy
|
1.8%
3/168 • Number of events 3
|
0.60%
1/168 • Number of events 1
|
3.0%
5/168 • Number of events 5
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
1.8%
3/168 • Number of events 3
|
1.2%
2/168 • Number of events 2
|
2.4%
4/168 • Number of events 4
|
|
General disorders
Others
|
7.1%
12/168 • Number of events 12
|
6.0%
10/168 • Number of events 10
|
6.0%
10/168 • Number of events 10
|
Additional Information
Qiuhe Ji
Department of Endocrinology, Xijing Hospital, Fourth Military Medical University
Phone: +86-29-84775213
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place