Trial · NCT02082769

Safety and Efficacy of Oral Febuxostat in Subjects With Gout

NCT02082769, Phase 3, Completed, Xijing Hospital; results first posted 2016-02-03

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Safety and Efficacy of Oral Febuxostat in Subjects With Gout. Trials, record NCT02082769. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02082769

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Oral Febuxostat in Subjects With Gout
NCT number: NCT02082769
Status: Completed
Phases: Phase 3
Enrollment: 504 participants, actual
Lead sponsor: Xijing Hospital
Conditions: Gout
Interventions: Febuxostat, Allopurinol
First posted: 2014-03-10
Last updated: 2016-02-03
Results first posted: 2016-02-03

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)	Last 3 visits (any last 3 visits up to week 26)
Secondary	Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit	Final Visit (up to 26 weeks)
Other	Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline	Baseline and Final Visit (up to 26 weeks)

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)	Last 3 visits (any last 3 visits up to week 26)	percentage of participants	NUMBER
SECONDARY	Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit	Final Visit (up to 26 weeks)	percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline	Baseline and Final Visit (up to 26 weeks)	umol/l	MEAN

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)	Febuxostat 40 mg QD	22.5		percentage of participants
Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)	Febuxostat 80 mg QD	33.5		percentage of participants
Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)	Allopurinol 100mg QD	17.0		percentage of participants
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit	Febuxostat 40 mg QD	45.0		percentage of participants
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit	Febuxostat 80 mg QD	58.9		percentage of participants
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit	Allopurinol 100mg QD	34.6		percentage of participants
Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline	Febuxostat 40 mg QD	182.2	Standard Deviation 115.6	umol/l
Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline	Febuxostat 80 mg QD	216.0	Standard Deviation 137.2	umol/l
Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline	Allopurinol 100mg QD	170.4	Standard Deviation 132.6	umol/l

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Febuxostat 40 mg QD	168
Overall Study	STARTED	Febuxostat 80 mg QD	168
Overall Study	STARTED	Allopurinol 100mg QD	168
Overall Study	COMPLETED	Febuxostat 40 mg QD	144
Overall Study	COMPLETED	Febuxostat 80 mg QD	141
Overall Study	COMPLETED	Allopurinol 100mg QD	132
Overall Study	NOT COMPLETED	Febuxostat 40 mg QD	24
Overall Study	NOT COMPLETED	Febuxostat 80 mg QD	27
Overall Study	NOT COMPLETED	Allopurinol 100mg QD	36

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Liver function test abnormalities	Hepatobiliary disorders	Febuxostat 40 mg QD	17	168	17
other	Liver function test abnormalities	Hepatobiliary disorders	Febuxostat 80 mg QD	22	168	22
other	Liver function test abnormalities	Hepatobiliary disorders	Allopurinol 100mg QD	18	168	18
other	Renal function test abnormalities	Renal and urinary disorders	Febuxostat 40 mg QD	2	168	2
other	Renal function test abnormalities	Renal and urinary disorders	Febuxostat 80 mg QD	7	168	7
other	Renal function test abnormalities	Renal and urinary disorders	Allopurinol 100mg QD	2	168	2
other	Abnormal electrocardiogram	Cardiac disorders	Febuxostat 40 mg QD	4	168	4
other	Abnormal electrocardiogram	Cardiac disorders	Febuxostat 80 mg QD	0	168	0
other	Abnormal electrocardiogram	Cardiac disorders	Allopurinol 100mg QD	1	168	1
other	Abnormal urine protein	Renal and urinary disorders	Febuxostat 40 mg QD	4	168	4

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Febuxostat 40 mg QD
Total, all-cause mortality	Febuxostat 80 mg QD
Total, all-cause mortality	Allopurinol 100mg QD
Total, other adverse events	Febuxostat 40 mg QD	45	168
Total, other adverse events	Febuxostat 80 mg QD	46	168
Total, other adverse events	Allopurinol 100mg QD	41	168
Total, serious adverse events	Febuxostat 40 mg QD	0	168
Total, serious adverse events	Febuxostat 80 mg QD	1	168
Total, serious adverse events	Allopurinol 100mg QD	0	168

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26013187	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02082769

GET https://conductscience.org/api/trials/v1/NCT02082769/events?page=2

API reference For AI assistants