Trial · NCT01399008

Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients

NCT01399008, Phase 2, Completed, Gilead Sciences; results first posted 2014-07-28

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients. Trials, record NCT01399008. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01399008

On this page

Trial

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

Title: Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients
NCT number: NCT01399008
Status: Completed
Phases: Phase 2
Enrollment: 100 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Gout
Interventions: Arhalofenate, Allopurinol, Colchicine, Placebo
First posted: 2011-07-21
Last updated: 2015-09-18
Results first posted: 2014-07-28

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Serum Uric Acid	Percent change from baseline in serum uric acid at Week 4	Percent change from baseline in serum uric acid in Per Protocol population

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Serum Uric Acid	Percent change from baseline in serum uric acid at Week 4	Per Protocol population (all randomized patients who received at least 1 dose of blinded study drug, had at least 1 post-treatment evaluation, had not violated any major entry criterion likely to confound an efficacy analysis and had not deviated significantly from the protocol between enrollment and study completion).	percent change	MEAN

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Value	Spread	Units
Serum Uric Acid	Arhalofenate 400 mg	-16.0	Standard Deviation 20.9	percent change
Serum Uric Acid	Arhalofenate 600 mg	-9.9	Standard Deviation 17.1	percent change
Serum Uric Acid	Placebo	-9.5	Standard Deviation 19.0	percent change

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arhalofenate 400 mg	35
Overall Study	STARTED	Arhalofenate 600 mg	32
Overall Study	STARTED	Placebo	33
Overall Study	COMPLETED	Arhalofenate 400 mg	32
Overall Study	COMPLETED	Arhalofenate 600 mg	27
Overall Study	COMPLETED	Placebo	31
Overall Study	NOT COMPLETED	Arhalofenate 400 mg	3
Overall Study	NOT COMPLETED	Arhalofenate 600 mg	5
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events12

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
other	Abdominal Pain Upper	Gastrointestinal disorders	Arhalofenate 400 mg Plus Allopurinol 300 mg	0	35
other	Abdominal Pain Upper	Gastrointestinal disorders	Arhalofenate 600 mg Plus Allopurinol 300 mg	2	32
other	Abdominal Pain Upper	Gastrointestinal disorders	Placebo Plus Allopurinol 300 mg	0	33
other	Headache	Nervous system disorders	Arhalofenate 400 mg Plus Allopurinol 300 mg	1	35
other	Headache	Nervous system disorders	Arhalofenate 600 mg Plus Allopurinol 300 mg	2	32
other	Headache	Nervous system disorders	Placebo Plus Allopurinol 300 mg	1	33
other	Upper respiratory tract infection	Infections and infestations	Arhalofenate 400 mg Plus Allopurinol 300 mg	0	35
other	Upper respiratory tract infection	Infections and infestations	Arhalofenate 600 mg Plus Allopurinol 300 mg	0	32
other	Upper respiratory tract infection	Infections and infestations	Placebo Plus Allopurinol 300 mg	2	33
other	Gout flare	Renal and urinary disorders	Arhalofenate 400 mg Plus Allopurinol 300 mg	10	35

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arhalofenate 400 mg Plus Allopurinol 300 mg
Total, all-cause mortality	Arhalofenate 600 mg Plus Allopurinol 300 mg
Total, all-cause mortality	Placebo Plus Allopurinol 300 mg
Total, other adverse events	Arhalofenate 400 mg Plus Allopurinol 300 mg	10	35
Total, other adverse events	Arhalofenate 600 mg Plus Allopurinol 300 mg	6	32
Total, other adverse events	Placebo Plus Allopurinol 300 mg	9	33
Total, serious adverse events	Arhalofenate 400 mg Plus Allopurinol 300 mg	0	35
Total, serious adverse events	Arhalofenate 600 mg Plus Allopurinol 300 mg	0	32
Total, serious adverse events	Placebo Plus Allopurinol 300 mg	0	33

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

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