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Safety and Efficacy of Oral Febuxostat in Subjects With Gout

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ClinicalTrials.gov Identifier: NCT02082769
Recruitment Status : Completed
First Posted : March 10, 2014
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Collaborator:
Qingdao Shengbang Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Xijing Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gout
Interventions Drug: Febuxostat
Drug: Allopurinol
Enrollment 504
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 100mg QD
Hide Arm/Group Description

Febuxostat 40 mg, orally, once daily for up to 24 weeks

Febuxostat

Febuxostat 80 mg, orally, once daily for up to 24 weeks

Febuxostat

Allopurinol 100mg, orally, three times daily for up to 24 weeks

Allopurinol

Period Title: Overall Study
Started 168 168 168
Completed 144 141 132
Not Completed 24 27 36
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 100mg QD Total
Hide Arm/Group Description

Febuxostat 40 mg, orally, once daily for up to 24 weeks

Febuxostat

Febuxostat 80 mg, orally, once daily for up to 24 weeks

Febuxostat

Allopurinol 100mg, orally, three times daily for up to 24 weeks

Allopurinol

Total of all reporting groups
Overall Number of Baseline Participants 160 158 159 477
Hide Baseline Analysis Population Description
full analysis set
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 158 participants 159 participants 477 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
160
 100.0%
158
 100.0%
159
 100.0%
477
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 160 participants 158 participants 159 participants 477 participants
45.5  (11.9) 48.2  (12.0) 46.5  (10.7) 46.7  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 158 participants 159 participants 477 participants
Female
158
  98.8%
146
  92.4%
149
  93.7%
453
  95.0%
Male
2
   1.3%
12
   7.6%
10
   6.3%
24
   5.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 160 participants 158 participants 159 participants 477 participants
25.2  (2.7) 25.1  (2.6) 25.4  (3.3) 25.2  (2.8)
Systolic blood pressure (SBP)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 160 participants 158 participants 159 participants 477 participants
126.2  (10.0) 126.4  (11.0) 124.8  (10.1) 126.4  (10.4)
Diastolic blood pressure (DBP)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 160 participants 158 participants 159 participants 477 participants
79.1  (8.2) 77.6  (8.1) 78.7  (7.9) 78.5  (8.1)
Baseline serum urate level units  
Mean (Standard Deviation)
Unit of measure:  Umol/l
Number Analyzed 160 participants 158 participants 159 participants 477 participants
560.8  (73.3) 565.1  (75.5) 574.2  (77.8) 566.7  (75.2)
1.Primary Outcome
Title Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)
Hide Description [Not Specified]
Time Frame Last 3 visits (any last 3 visits up to week 26)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 100mg QD
Hide Arm/Group Description:

Febuxostat 40 mg, orally, once daily for up to 24 weeks

Febuxostat

Febuxostat 80 mg, orally, once daily for up to 24 weeks

Febuxostat

Allopurinol 100mg, orally, three times daily for up to 24 weeks

Allopurinol

Overall Number of Participants Analyzed 160 158 159
Measure Type: Number
Unit of Measure: percentage of participants
22.5 33.5 17.0
2.Secondary Outcome
Title Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit
Hide Description [Not Specified]
Time Frame Final Visit (up to 26 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 100mg QD
Hide Arm/Group Description:

Febuxostat 40 mg, orally, once daily for up to 24 weeks

Febuxostat

Febuxostat 80 mg, orally, once daily for up to 24 weeks

Febuxostat

Allopurinol 100mg, orally, three times daily for up to 24 weeks

Allopurinol

Overall Number of Participants Analyzed 160 158 159
Measure Type: Number
Unit of Measure: percentage of participants
45.0 58.9 34.6
3.Other Pre-specified Outcome
Title Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline
Hide Description [Not Specified]
Time Frame Baseline and Final Visit (up to 26 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 100mg QD
Hide Arm/Group Description:

Febuxostat 40 mg, orally, once daily for up to 24 weeks

Febuxostat

Febuxostat 80 mg, orally, once daily for up to 24 weeks

Febuxostat

Allopurinol 100mg, orally, three times daily for up to 24 weeks

Allopurinol

Overall Number of Participants Analyzed 160 158 159
Mean (Standard Deviation)
Unit of Measure: umol/l
182.2  (115.6) 216.0  (137.2) 170.4  (132.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 100mg QD
Hide Arm/Group Description

Febuxostat 40 mg, orally, once daily for up to 24 weeks

Febuxostat

Febuxostat 80 mg, orally, once daily for up to 24 weeks

Febuxostat

Allopurinol 100mg, orally, three times daily for up to 24 weeks

Allopurinol

All-Cause Mortality
Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 100mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 100mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/168 (0.00%)      1/168 (0.60%)      0/168 (0.00%)    
Renal and urinary disorders       
hydronephrosis  [1]  0/168 (0.00%)  0 1/168 (0.60%)  1 0/168 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
The subject was diagnosed as hydronephrosis after 14-day period of febuxostat administration and thus hospitalized.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Febuxostat 40 mg QD Febuxostat 80 mg QD Allopurinol 100mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/168 (26.79%)      46/168 (27.38%)      41/168 (24.40%)    
Cardiac disorders       
Abnormal electrocardiogram   4/168 (2.38%)  4 0/168 (0.00%)  0 1/168 (0.60%)  1
Gastrointestinal disorders       
Gastrointestinal disorders   3/168 (1.79%)  3 2/168 (1.19%)  2 4/168 (2.38%)  4
General disorders       
Others   12/168 (7.14%)  12 10/168 (5.95%)  10 10/168 (5.95%)  10
Hepatobiliary disorders       
Liver function test abnormalities   17/168 (10.12%)  17 22/168 (13.10%)  22 18/168 (10.71%)  18
Renal and urinary disorders       
Renal function test abnormalities   2/168 (1.19%)  2 7/168 (4.17%)  7 2/168 (1.19%)  2
Abnormal urine protein   4/168 (2.38%)  4 4/168 (2.38%)  4 1/168 (0.60%)  1
Skin and subcutaneous tissue disorders       
Drug allergy   3/168 (1.79%)  3 1/168 (0.60%)  1 5/168 (2.98%)  5
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Qiuhe Ji
Organization: Department of Endocrinology, Xijing Hospital, Fourth Military Medical University
Phone: +86-29-84775213
Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02082769     History of Changes
Other Study ID Numbers: SFDA2010L04287
First Submitted: March 6, 2014
First Posted: March 10, 2014
Results First Submitted: May 11, 2015
Results First Posted: February 3, 2016
Last Update Posted: February 3, 2016