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Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02128490
Recruitment Status : Completed
First Posted : May 1, 2014
Results First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Gout
Moderate Renal Impairment
Interventions Drug: Febuxostat IR
Drug: Febuxostat XR
Drug: Febuxostat placebo
Drug: Colchicine
Drug: Naproxen
Drug: Lansoprazole
Enrollment 189
Recruitment Details Participants took part in the study at 65 investigative sites in the United States from 5 May 2014 to 23 October 2015.
Pre-assignment Details 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.
Arm/Group Title Placebo Febuxostat IR 40 mg Febuxostat XR 40 mg Febuxostat IR 80 mg Febuxostat XR 80 mg
Hide Arm/Group Description 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 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 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 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 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.
Period Title: Overall Study
Started 38 37 39 37 38
Completed 33 31 34 31 31
Not Completed 5 6 5 6 7
Reason Not Completed
Pretreatment Event/Adverse Event             1             0             1             1             0
Major Protocol Deviation             1             2             0             2             2
Lost to Follow-up             0             0             1             1             1
Voluntary Withdrawal             3             3             1             1             2
Lack of Efficacy             0             1             0             0             0
Withdraw from Study Drug, Gout Flare             0             0             0             0             1
Other Miscellaneous Reasons             0             0             2             1             1
Arm/Group Title Placebo Febuxostat IR 40 mg Febuxostat XR 40 mg Febuxostat IR 80 mg Febuxostat XR 80 mg Total
Hide Arm/Group Description 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 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 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 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 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 of all reporting groups
Overall Number of Baseline Participants 38 37 39 37 38 189
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 37 participants 39 participants 37 participants 38 participants 189 participants
64.6  (12.78) 61.3  (10.09) 64.4  (11.21) 63.5  (10.33) 61.4  (12.17) 63.1  (11.34)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 39 participants 37 participants 38 participants 189 participants
< 45 years 1 3 1 0 4 9
45 to < 65 years 14 16 15 18 18 81
>= 65 years 23 18 23 19 16 99
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 39 participants 37 participants 38 participants 189 participants
18 to < 65 years 15 19 16 18 22 90
65 to < 85 years 21 18 23 19 16 97
>= 85 years 2 0 0 0 0 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 39 participants 37 participants 38 participants 189 participants
Female
12
  31.6%
12
  32.4%
13
  33.3%
9
  24.3%
9
  23.7%
55
  29.1%
Male
26
  68.4%
25
  67.6%
26
  66.7%
28
  75.7%
29
  76.3%
134
  70.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 39 participants 37 participants 38 participants 189 participants
Asian 0 2 1 2 4 9
Black or African American 4 10 10 12 10 46
Native Hawaiian or Other Pacific Islander 1 0 1 2 0 4
White 33 24 26 21 22 126
Other: Multi-racial 0 1 1 0 2 4
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 39 participants 37 participants 38 participants 189 participants
Hispanic or Latino 2 1 7 7 7 24
Not Hispanic or Latino 36 36 32 30 31 165
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants 37 participants 39 participants 37 participants 38 participants 189 participants
38 37 39 37 38 189
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 38 participants 37 participants 39 participants 37 participants 38 participants 189 participants
171.5  (10.47) 172.8  (10.39) 171.6  (9.99) 170.7  (11.16) 173.4  (9.63) 172.0  (10.27)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 38 participants 37 participants 39 participants 37 participants 38 participants 189 participants
100.76  (25.675) 108.52  (25.451) 103.75  (27.027) 96.43  (21.749) 98.44  (22.844) 101.58  (24.749)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 38 participants 37 participants 39 participants 37 participants 38 participants 189 participants
34.08  (6.993) 36.53  (9.036) 35.23  (8.655) 33.10  (7.220) 32.62  (6.609) 34.31  (7.810)
Smoking History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 39 participants 37 participants 38 participants 189 participants
Never Smoked 20 21 19 20 16 96
Current Smoker 2 3 4 5 5 19
Ex-Smoker 16 13 16 12 17 74
Alcohol Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 37 participants 39 participants 37 participants 38 participants 189 participants
Never Drank 8 14 14 19 20 75
Current Drinker 22 15 15 14 13 79
Ex-Drinker 8 8 10 4 5 35
1.Primary Outcome
Title Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3
Hide Description [Not Specified]
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Febuxostat IR 40 mg Febuxostat XR 40 mg Febuxostat IR 80 mg Febuxostat XR 80 mg
Hide Arm/Group Description:
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 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 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 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 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 Number of Participants Analyzed 38 37 39 37 38
Measure Type: Number
Unit of Measure: percentage of participants
0 13.5 35.9 40.5 44.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Febuxostat XR 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 35.9
Confidence Interval (2-Sided) 95%
20.8 to 51.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Febuxostat XR 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 44.7
Confidence Interval (2-Sided) 95%
28.9 to 60.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat IR 40 mg, Febuxostat XR 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 22.4
Confidence Interval (2-Sided) 95%
3.7 to 41.0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Febuxostat IR 80 mg, Febuxostat XR 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.817
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
-18.2 to 26.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With at Least One Gout Flare Requiring Treatment
Hide Description

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.

Time Frame Baseline to Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.
Arm/Group Title Placebo Febuxostat IR 40 mg Febuxostat XR 40 mg Febuxostat IR 80 mg Febuxostat XR 80 mg
Hide Arm/Group Description:
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 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 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 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 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 Number of Participants Analyzed 38 37 39 37 38
Measure Type: Number
Unit of Measure: percentage of participants
10.5 40.5 23.1 37.8 42.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Febuxostat XR 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.224
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 12.6
Confidence Interval (2-Sided) 95%
-3.9 to 29.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Febuxostat XR 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 31.6
Confidence Interval (2-Sided) 95%
13.1 to 50.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat IR 40 mg, Febuxostat XR 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.139
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value -17.5
Confidence Interval (2-Sided) 95%
-38.1 to 3.2
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Febuxostat IR 80 mg, Febuxostat XR 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.815
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
-17.9 to 26.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3
Hide Description [Not Specified]
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Febuxostat IR 40 mg Febuxostat XR 40 mg Febuxostat IR 80 mg Febuxostat XR 80 mg
Hide Arm/Group Description:
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 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 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 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 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 Number of Participants Analyzed 38 37 39 37 38
Measure Type: Number
Unit of Measure: percentage of participants
0 32.4 53.8 59.5 55.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Febuxostat XR 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 53.8
Confidence Interval (2-Sided) 95%
38.2 to 69.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Febuxostat XR 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 55.3
Confidence Interval (2-Sided) 95%
39.5 to 71.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Febuxostat IR 40 mg, Febuxostat XR 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 21.4
Confidence Interval (2-Sided) 95%
-0.3 to 43.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Febuxostat IR 80 mg, Febuxostat XR 80 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.817
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-26.6 to 18.2
Estimation Comments [Not Specified]
Time Frame First dose of double-blind study drug to 30 days past last dose of double-blind study drug (Up to 4 Months)
Adverse Event Reporting Description 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.
 
Arm/Group Title Placebo Febuxostat IR 40 mg Febuxostat XR 40 mg Febuxostat IR 80 mg Febuxostat XR 80 mg
Hide Arm/Group Description 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 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 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 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 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.
All-Cause Mortality
Placebo Febuxostat IR 40 mg Febuxostat XR 40 mg Febuxostat IR 80 mg Febuxostat XR 80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Febuxostat IR 40 mg Febuxostat XR 40 mg Febuxostat IR 80 mg Febuxostat XR 80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   1/37 (2.70%)   1/39 (2.56%)   0/37 (0.00%)   4/38 (10.53%) 
Cardiac disorders           
Coronary artery disease  1  0/38 (0.00%)  0/37 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  1/38 (2.63%) 
Sinus node dusfunction  1  0/38 (0.00%)  0/37 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  1/38 (2.63%) 
Cardiac arrest  1 [1]  0/38 (0.00%)  0/37 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  1/38 (2.63%) 
Hepatobiliary disorders           
Cholelithiasis  1  0/38 (0.00%)  0/37 (0.00%)  1/39 (2.56%)  0/37 (0.00%)  0/38 (0.00%) 
Infections and infestations           
Gastroenteritis  1  0/38 (0.00%)  1/37 (2.70%)  0/39 (0.00%)  0/37 (0.00%)  0/38 (0.00%) 
Gangrene  1  0/38 (0.00%)  0/37 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  1/38 (2.63%) 
Renal and urinary disorders           
Acute kidney injury  1  0/38 (0.00%)  1/37 (2.70%)  0/39 (0.00%)  0/37 (0.00%)  0/38 (0.00%) 
Vascular disorders           
Hypertension  1  0/38 (0.00%)  0/37 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  1/38 (2.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
[1]
One treatment-emergent death occurred during treatment with febuxostat XR 80 mg and is not related.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Febuxostat IR 40 mg Febuxostat XR 40 mg Febuxostat IR 80 mg Febuxostat XR 80 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/38 (7.89%)   5/37 (13.51%)   4/39 (10.26%)   1/37 (2.70%)   3/38 (7.89%) 
Cardiac disorders           
Palpitations  1  0/38 (0.00%)  0/37 (0.00%)  2/39 (5.13%)  0/37 (0.00%)  0/38 (0.00%) 
Gastrointestinal disorders           
Diarrhoea  1  0/38 (0.00%)  2/37 (5.41%)  0/39 (0.00%)  0/37 (0.00%)  0/38 (0.00%) 
Infections and infestations           
Urinary tract infection  1  0/38 (0.00%)  2/37 (5.41%)  0/39 (0.00%)  0/37 (0.00%)  0/38 (0.00%) 
Metabolism and nutrition disorders           
Hyperglycaemia  1  0/38 (0.00%)  0/37 (0.00%)  2/39 (5.13%)  0/37 (0.00%)  0/38 (0.00%) 
Renal and urinary disorders           
Renal failure  1  2/38 (5.26%)  0/37 (0.00%)  0/39 (0.00%)  0/37 (0.00%)  0/38 (0.00%) 
Vascular disorders           
Hypertension  1  1/38 (2.63%)  1/37 (2.70%)  0/39 (0.00%)  1/37 (2.70%)  3/38 (7.89%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02128490     History of Changes
Other Study ID Numbers: FEB-XR_201
U1111-1152-3942 ( Other Identifier: World Health Organization )
First Submitted: April 29, 2014
First Posted: May 1, 2014
Results First Submitted: September 15, 2016
Results First Posted: November 3, 2016
Last Update Posted: November 3, 2016