Trial · NCT01510769

Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat

NCT01510769, Phase 3, Completed, Ardea Biosciences, Inc.; results first posted 2016-05-26

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat. Trials, record NCT01510769. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01510769

On this page

Trial

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

Title: Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat
NCT number: NCT01510769
Status: Completed
Phases: Phase 3
Enrollment: 330 participants, actual
Lead sponsor: Ardea Biosciences, Inc.
Conditions: Tophaceous Gout
Interventions: Lesinurad, Lesinurad, Placebo, Febuxostat
First posted: 2012-01-16
Last updated: 2016-05-26
Other registries' IDs: eudract:2011-003768-55
Results first posted: 2016-05-26

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6	6 months, analysis after all subjects complete 12 months	Proportion of subjects with an sUA level that is \< 5.0 mg/dL by Month 6
Secondary	Complete Resolution of at Least One Target Tophus	12 Months	Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12
Secondary	Complete or Partial Response of at Least One Tophus	12 Months	Proportion of subjects with a best tophus response on at least 1 target tophus of complete (disappearance of at least 1 target tophus) or partial (≥ 50% decrease in the area of at least 1 target tophus) resolution by Month 12
Secondary	Quality of Life	12 Months	Proportion of subjects with an improvement from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at least 0.25 at Month 12. The HAQ-DI assesses a patient's level of functional ability with items scores ranging from 0-3 with 0 being the least disability.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6	6 months, analysis after all subjects complete 12 months	Intent-to-Treat Population	Proportion of Subjects	NUMBER
SECONDARY	Complete Resolution of at Least One Target Tophus	12 Months	Intent-to-Treat Population	Proportion of Subjects	NUMBER
SECONDARY	Complete or Partial Response of at Least One Tophus	12 Months	Intent-to-Treat Population	Proportion of Subjects	NUMBER
SECONDARY	Quality of Life	12 Months	Intent-to-Treat Population	Proportion of Subjects	NUMBER

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Units
Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6	Lesinurad 200 mg + Febuxostat 80 mg	0.566	Proportion of Subjects
Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6	Lesinurad 400 mg + Febuxostat 80 mg	0.761	Proportion of Subjects
Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6	Placebo + Febuxostat 80 mg	0.468	Proportion of Subjects
Complete Resolution of at Least One Target Tophus	Lesinurad 200 mg + Febuxostat 80 mg	0.255	Proportion of Subjects
Complete Resolution of at Least One Target Tophus	Lesinurad 400 mg + Febuxostat 80 mg	0.303	Proportion of Subjects
Complete Resolution of at Least One Target Tophus	Placebo + Febuxostat 80 mg	0.211	Proportion of Subjects
Complete or Partial Response of at Least One Tophus	Lesinurad 200 mg + Febuxostat 80 mg	0.566	Proportion of Subjects
Complete or Partial Response of at Least One Tophus	Lesinurad 400 mg + Febuxostat 80 mg	0.587	Proportion of Subjects
Complete or Partial Response of at Least One Tophus	Placebo + Febuxostat 80 mg	0.505	Proportion of Subjects
Quality of Life	Lesinurad 200 mg + Febuxostat 80 mg	0.442	Proportion of Subjects

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lesinurad 200 mg + Febuxostat	106
Overall Study	STARTED	Lesinurad 400 mg + Febuxostat	109
Overall Study	STARTED	Placebo + Febuxostat	109
Overall Study	COMPLETED	Lesinurad 200 mg + Febuxostat	79
Overall Study	COMPLETED	Lesinurad 400 mg + Febuxostat	84
Overall Study	COMPLETED	Placebo + Febuxostat	87
Overall Study	NOT COMPLETED	Lesinurad 200 mg + Febuxostat	27
Overall Study	NOT COMPLETED	Lesinurad 400 mg + Febuxostat	25
Overall Study	NOT COMPLETED	Placebo + Febuxostat	22

Source ClinicalTrials.gov

Adverse events135

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	Dental caries	Gastrointestinal disorders	Lesinurad 200 mg + Febuxostat	0	106	0
other	Dental caries	Gastrointestinal disorders	Lesinurad 400 mg + Febuxostat	3	109	3
other	Dental caries	Gastrointestinal disorders	Placebo + Febuxostat	0	109	0
other	Toothache	Gastrointestinal disorders	Lesinurad 200 mg + Febuxostat	1	106	1
other	Toothache	Gastrointestinal disorders	Lesinurad 400 mg + Febuxostat	3	109	3
other	Toothache	Gastrointestinal disorders	Placebo + Febuxostat	0	109	0
other	Non-cardiac chest pain	General disorders	Lesinurad 200 mg + Febuxostat	1	106	1
other	Non-cardiac chest pain	General disorders	Lesinurad 400 mg + Febuxostat	3	109	4
other	Non-cardiac chest pain	General disorders	Placebo + Febuxostat	0	109	0
other	Pyrexia	General disorders	Lesinurad 200 mg + Febuxostat	1	106	1

1 to 10 of 135Source ClinicalTrials.gov

See all 135 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lesinurad 200 mg + Febuxostat
Total, all-cause mortality	Lesinurad 400 mg + Febuxostat
Total, all-cause mortality	Placebo + Febuxostat
Total, other adverse events	Lesinurad 200 mg + Febuxostat	50	106
Total, other adverse events	Lesinurad 400 mg + Febuxostat	59	109
Total, other adverse events	Placebo + Febuxostat	34	109
Total, serious adverse events	Lesinurad 200 mg + Febuxostat	6	106
Total, serious adverse events	Lesinurad 400 mg + Febuxostat	9	109
Total, serious adverse events	Placebo + Febuxostat	10	109

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28597604	DERIVED	PubMed
30616614	DERIVED	PubMed
35835008	DERIVED	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/NCT01510769

GET https://conductscience.org/api/trials/v1/NCT01510769/events?page=2

API reference For AI assistants