Trial Outcomes & Findings for Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment (NCT NCT02128490)
NCT ID: NCT02128490
Last Updated: 2016-11-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
189 participants
Primary outcome timeframe
Month 3
Results posted on
2016-11-03
Participant Flow
Participants took part in the study at 65 investigative sites in the United States from 5 May 2014 to 23 October 2015.
Participants with a diagnosis of gout were enrolled equally in 1 of 5 treatment groups once a day: placebo, febuxostat 40 mg extended release (XR), febuxostat 80 mg XR, febuxostat 40 mg immediate release (IR) or febuxostat 80 mg IR.
Participant milestones
| Measure |
Placebo
Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 40 mg
Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 40 mg
Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 80 mg
Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 80 mg
Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
38
|
37
|
39
|
37
|
38
|
|
Overall Study
COMPLETED
|
33
|
31
|
34
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
5
|
6
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 40 mg
Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 40 mg
Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 80 mg
Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 80 mg
Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
|---|---|---|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Major Protocol Deviation
|
1
|
2
|
0
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Voluntary Withdrawal
|
3
|
3
|
1
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdraw from Study Drug, Gout Flare
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Other Miscellaneous Reasons
|
0
|
0
|
2
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment
Baseline characteristics by cohort
| Measure |
Placebo
n=38 Participants
Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 40 mg
n=37 Participants
Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 40 mg
n=39 Participants
Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 80 mg
n=37 Participants
Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 80 mg
n=38 Participants
Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
< 45 years
|
1 participants
n=93 Participants
|
3 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
4 participants
n=36 Participants
|
9 participants
n=10 Participants
|
|
Age, Customized
45 to < 65 years
|
14 participants
n=93 Participants
|
16 participants
n=4 Participants
|
15 participants
n=27 Participants
|
18 participants
n=483 Participants
|
18 participants
n=36 Participants
|
81 participants
n=10 Participants
|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 12.78 • n=93 Participants
|
61.3 years
STANDARD_DEVIATION 10.09 • n=4 Participants
|
64.4 years
STANDARD_DEVIATION 11.21 • n=27 Participants
|
63.5 years
STANDARD_DEVIATION 10.33 • n=483 Participants
|
61.4 years
STANDARD_DEVIATION 12.17 • n=36 Participants
|
63.1 years
STANDARD_DEVIATION 11.34 • n=10 Participants
|
|
Age, Customized
>= 65 years
|
23 participants
n=93 Participants
|
18 participants
n=4 Participants
|
23 participants
n=27 Participants
|
19 participants
n=483 Participants
|
16 participants
n=36 Participants
|
99 participants
n=10 Participants
|
|
Age, Customized
18 to < 65 years
|
15 participants
n=93 Participants
|
19 participants
n=4 Participants
|
16 participants
n=27 Participants
|
18 participants
n=483 Participants
|
22 participants
n=36 Participants
|
90 participants
n=10 Participants
|
|
Age, Customized
65 to < 85 years
|
21 participants
n=93 Participants
|
18 participants
n=4 Participants
|
23 participants
n=27 Participants
|
19 participants
n=483 Participants
|
16 participants
n=36 Participants
|
97 participants
n=10 Participants
|
|
Age, Customized
>= 85 years
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
2 participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
55 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
29 Participants
n=36 Participants
|
134 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
1 participants
n=27 Participants
|
2 participants
n=483 Participants
|
4 participants
n=36 Participants
|
9 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 participants
n=93 Participants
|
10 participants
n=4 Participants
|
10 participants
n=27 Participants
|
12 participants
n=483 Participants
|
10 participants
n=36 Participants
|
46 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
2 participants
n=483 Participants
|
0 participants
n=36 Participants
|
4 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
33 participants
n=93 Participants
|
24 participants
n=4 Participants
|
26 participants
n=27 Participants
|
21 participants
n=483 Participants
|
22 participants
n=36 Participants
|
126 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other: Multi-racial
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
2 participants
n=36 Participants
|
4 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
7 participants
n=27 Participants
|
7 participants
n=483 Participants
|
7 participants
n=36 Participants
|
24 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
36 participants
n=93 Participants
|
36 participants
n=4 Participants
|
32 participants
n=27 Participants
|
30 participants
n=483 Participants
|
31 participants
n=36 Participants
|
165 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=93 Participants
|
37 participants
n=4 Participants
|
39 participants
n=27 Participants
|
37 participants
n=483 Participants
|
38 participants
n=36 Participants
|
189 participants
n=10 Participants
|
|
Height
|
171.5 cm
STANDARD_DEVIATION 10.47 • n=93 Participants
|
172.8 cm
STANDARD_DEVIATION 10.39 • n=4 Participants
|
171.6 cm
STANDARD_DEVIATION 9.99 • n=27 Participants
|
170.7 cm
STANDARD_DEVIATION 11.16 • n=483 Participants
|
173.4 cm
STANDARD_DEVIATION 9.63 • n=36 Participants
|
172.0 cm
STANDARD_DEVIATION 10.27 • n=10 Participants
|
|
Weight
|
100.76 kg
STANDARD_DEVIATION 25.675 • n=93 Participants
|
108.52 kg
STANDARD_DEVIATION 25.451 • n=4 Participants
|
103.75 kg
STANDARD_DEVIATION 27.027 • n=27 Participants
|
96.43 kg
STANDARD_DEVIATION 21.749 • n=483 Participants
|
98.44 kg
STANDARD_DEVIATION 22.844 • n=36 Participants
|
101.58 kg
STANDARD_DEVIATION 24.749 • n=10 Participants
|
|
Body Mass Index (BMI)
|
34.08 kg/m^2
STANDARD_DEVIATION 6.993 • n=93 Participants
|
36.53 kg/m^2
STANDARD_DEVIATION 9.036 • n=4 Participants
|
35.23 kg/m^2
STANDARD_DEVIATION 8.655 • n=27 Participants
|
33.10 kg/m^2
STANDARD_DEVIATION 7.220 • n=483 Participants
|
32.62 kg/m^2
STANDARD_DEVIATION 6.609 • n=36 Participants
|
34.31 kg/m^2
STANDARD_DEVIATION 7.810 • n=10 Participants
|
|
Smoking History
Never Smoked
|
20 participants
n=93 Participants
|
21 participants
n=4 Participants
|
19 participants
n=27 Participants
|
20 participants
n=483 Participants
|
16 participants
n=36 Participants
|
96 participants
n=10 Participants
|
|
Smoking History
Current Smoker
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
4 participants
n=27 Participants
|
5 participants
n=483 Participants
|
5 participants
n=36 Participants
|
19 participants
n=10 Participants
|
|
Smoking History
Ex-Smoker
|
16 participants
n=93 Participants
|
13 participants
n=4 Participants
|
16 participants
n=27 Participants
|
12 participants
n=483 Participants
|
17 participants
n=36 Participants
|
74 participants
n=10 Participants
|
|
Alcohol Classification
Never Drank
|
8 participants
n=93 Participants
|
14 participants
n=4 Participants
|
14 participants
n=27 Participants
|
19 participants
n=483 Participants
|
20 participants
n=36 Participants
|
75 participants
n=10 Participants
|
|
Alcohol Classification
Current Drinker
|
22 participants
n=93 Participants
|
15 participants
n=4 Participants
|
15 participants
n=27 Participants
|
14 participants
n=483 Participants
|
13 participants
n=36 Participants
|
79 participants
n=10 Participants
|
|
Alcohol Classification
Ex-Drinker
|
8 participants
n=93 Participants
|
8 participants
n=4 Participants
|
10 participants
n=27 Participants
|
4 participants
n=483 Participants
|
5 participants
n=36 Participants
|
35 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.
Outcome measures
| Measure |
Placebo
n=38 Participants
Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 40 mg
n=37 Participants
Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 40 mg
n=39 Participants
Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 80 mg
n=37 Participants
Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 80 mg
n=38 Participants
Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3
|
0 percentage of participants
|
13.5 percentage of participants
|
35.9 percentage of participants
|
40.5 percentage of participants
|
44.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Month 3Population: FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.
A participant was considered to have a gout flare if the following criteria were met: Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare.
Outcome measures
| Measure |
Placebo
n=38 Participants
Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 40 mg
n=37 Participants
Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 40 mg
n=39 Participants
Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 80 mg
n=37 Participants
Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 80 mg
n=38 Participants
Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Gout Flare Requiring Treatment
|
10.5 percentage of participants
|
40.5 percentage of participants
|
23.1 percentage of participants
|
37.8 percentage of participants
|
42.1 percentage of participants
|
SECONDARY outcome
Timeframe: Month 3Population: FAS included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.
Outcome measures
| Measure |
Placebo
n=38 Participants
Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 40 mg
n=37 Participants
Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 40 mg
n=39 Participants
Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 80 mg
n=37 Participants
Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 80 mg
n=38 Participants
Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3
|
0 percentage of participants
|
32.4 percentage of participants
|
53.8 percentage of participants
|
59.5 percentage of participants
|
55.3 percentage of participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Febuxostat IR 40 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Febuxostat XR 40 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Febuxostat IR 80 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Febuxostat XR 80 mg
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=38 participants at risk
Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 40 mg
n=37 participants at risk
Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 40 mg
n=39 participants at risk
Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 80 mg
n=37 participants at risk
Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 80 mg
n=38 participants at risk
Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Sinus node dusfunction
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.7%
1/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gangrene
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.7%
1/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.6%
1/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo
n=38 participants at risk
Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 40 mg
n=37 participants at risk
Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 40 mg
n=39 participants at risk
Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat IR 80 mg
n=37 participants at risk
Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
Febuxostat XR 80 mg
n=38 participants at risk
Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.1%
2/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.4%
2/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.4%
2/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.1%
2/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal failure
|
5.3%
2/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
2.6%
1/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.7%
1/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/39 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.7%
1/37 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.9%
3/38 • First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER