GoutPhase 2FOCUSNCT00174941

Long-Term Safety of Febuxostat in Subjects With Gout.

A Phase 2 study testing Febuxostat in people with Gout, run by Takeda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Gout
What is being tested?: Febuxostat
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: No sites listed yet
Study dates: Mar 2001to Dec 2006
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Hyperuricemia (serum uric acid ≥8.0 mg/dL upon entering parent study TMX-00-004).
Must meet American College of Rheumatology criteria for gout.
Must have adequate renal function (serum creatinine <1.5 mg/dL).
Must have completed four weeks of double-blind dosing in Study TMX-00-004.
Must not have experienced any serious study drug-related Adverse Events in Study TMX 00-004.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Who cannot join

History of xanthinuria
Alcohol consumption >14/week
Has a History of significant concomitant illness
Has active liver disease.
Has a body mass index greater than 50 kg/m2
Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.

About this study

Official title: Phase II, Open-Label Study, to Assess the Long-Term Safety of Oral TMX-67 in Subjects With Gout

The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.

Read the detailed description

Uric acid is the end product of purine degradation in humans. Hyperuricemia, a urate concentration in serum exceeding the limit of urate solubility (approximately 7.0 milligrams per deciliter [mg/dL]), is a common biochemical abnormality. Aberrations in any of the multiple mechanisms involved in the production and/or excretion of uric acid may increase serum urate concentrations, with persistent hyperuricemia as a marker for extracellular fluid monosodium urate supersaturation. As such, hyperuricemia is a necessary (but often not sufficient) risk factor for monosodium urate crystal deposition in tissues and is the fundamental pathophysiological process underlying the clinical manifestations of gout, which is a chronic disease characterized by urate crystal formation and deposition in joints and bones. Gout may progress from episodic attacks of acute inflammatory arthritis to a disabling chronic disorder characterized by deforming arthropathy; destructive deposits of urate crystals (tophi) in bones, joints, and other organs; structural and functional renal impairment due to interstitial urate crystal deposition; and urinary tract stones composed entirely or in part of uric acid crystals. Management of gout requires chronic treatment aimed at lowering serum urate into a subsaturating range (usually <6.0 mg/dL) in which crystal formation and deposition are prevented or reversed.

Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

Subjects who want to participate in this study will have successfully completed study TMX-00-004 (NCT00174967).

All participants will initially receive an 80 mg dose. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.

Conditions: Gout
Being tested: Febuxostat
Keywords: Uric acid, xanthine oxidase, tophi, Drug Therapy
Medical subject headings: Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FebuxostatDrug
Also called TMX-67, Tei-6720, Uloric
Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level.
FebuxostatDrug
Also called TMX-67, Tei-6720, Uloric
Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level.
FebuxostatDrug
Also called TMX-67, Tei-6720, Uloric
Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.

Study groups in NCT00174941
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Febuxostat
2	Experimental	Not described Receives: Drug: Febuxostat
3	Experimental	Not described Receives: Drug: Febuxostat

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit.
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.
Measured: Month 6
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit.
Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized.
Measured: Month 12
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit.
Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 18 visit was summarized.
Measured: Month 18
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit.
Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized.
Measured: Month 24
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit.
Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized.
Measured: Month 36
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit.
Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 48 visit was summarized.
Measured: Month 48
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit.
Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 60 visit was summarized.
Measured: Month 60
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit.
The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.
Measured: Last Visit on treatment (up to 66 months).

Secondary outcomes (8)

Percent Change in Serum Urate Levels From Baseline at Month 6 Visit.
Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.
Measured: Baseline and Month 6
Percent Change in Serum Urate Levels From Baseline at Month 12 Visit.
Serum urate values were obtained at the Month 12 visit. The percent change in serum urate from baseline to the Month 12 visit was summarized.
Measured: Baseline and Month 12
Percent Change in Serum Urate Levels From Baseline at Month 18 Visit.
Serum urate values were obtained at the Month 18 visit. The percent change in serum urate from baseline to the Month 18 visit was summarized.
Measured: Baseline and Month 18
Percent Change in Serum Urate Levels From Baseline at Month 24 Visit.
Serum urate values were obtained at the Month 24 visit. The percent change in serum urate from baseline to the Month 24 visit was summarized.
Measured: Baseline and Month 24
Percent Change in Serum Urate Levels From Baseline at Month 36 Visit.
Serum urate values were obtained at the Month 36 visit. The percent change in serum urate from baseline to the Month 36 visit was summarized.
Measured: Baseline and Month 36
Percent Change in Serum Urate Levels From Baseline at Month 48 Visit.
Serum urate values were obtained at the Month 48 visit. The percent change in serum urate from baseline to the Month 48 visit was summarized.
Measured: Baseline and Month 48
Percent Change in Serum Urate Levels From Baseline at Month 60 Visit.
The secondary outcome was the mean percent change from baseline to Month 60 visit as assessed by serum urate levels collected at baseline and at the Month 60 visit by dose at observation.
Measured: Baseline and Month 60
Percent Change in Serum Urate Levels From Baseline at Final Visit.
The percent change in serum urate from baseline to the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.
Measured: Baseline and Last Visit on treatment (up to 66 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2001Dec 2006

First posted15 Sep 2005 (estimated)
Study startMar 2001
Primary completionDec 2006
Study completionDec 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for GoutStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00174941
Sponsor's protocol ID: TMX-01-005
Other IDs: U1111-1114-2039
Acronym: FOCUS
Status last verified: Jan 2011
First submitted: 12 Sep 2005
Last updated: 27 Jan 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Colwell HH, Hunt BJ, Pasta DJ, Palo WA, Mathias SD, Joseph-Ridge N. Gout Assessment Questionnaire: Initial results of reliability, validity and responsiveness. Int J Clin Pract. 2006 Oct;60(10):1210-7. doi: 10.1111/j.1742-1241.2006.01104.x. Epub 2006 Aug 15.
PubMed 16911575
Schumacher HR Jr, Becker MA, Lloyd E, MacDonald PA, Lademacher C. Febuxostat in the treatment of gout: 5-yr findings of the FOCUS efficacy and safety study. Rheumatology (Oxford). 2009 Feb;48(2):188-94. doi: 10.1093/rheumatology/ken457.
PubMed 19141576
Whelton A, Macdonald PA, Zhao L, Hunt B, Gunawardhana L. Renal function in gout: long-term treatment effects of febuxostat. J Clin Rheumatol. 2011 Jan;17(1):7-13. doi: 10.1097/RHU.0b013e318204aab4.
PubMed 21169856

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy

All Gout trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II, Open-Label Study, to Assess the Long-Term Safety of Oral TMX-67 in Subjects With Gout
ClinicalTrials.gov ID: NCT00174941
Acronym / sponsor ID: FOCUS / TMX-01-005
Conditions: Gout
Keywords: Uric acid, xanthine oxidase, tophi, Drug Therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Mar 2001
Primary completion: Dec 2006 (actual)
Study completion: Dec 2006 (actual)
First posted: 15 Sep 2005 (estimated)
Results: Posted 16 Jul 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.

Detailed description

Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

Subjects who want to participate in this study will have successfully completed study TMX-00-004 (NCT00174967).

All participants will initially receive an 80 mg dose. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Febuxostat
2	Experimental	Drug: Febuxostat
3	Experimental	Drug: Febuxostat

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Hyperuricemia (serum uric acid ≥8.0 mg/dL upon entering parent study TMX-00-004).
Must meet American College of Rheumatology criteria for gout.
Must have adequate renal function (serum creatinine <1.5 mg/dL).
Must have completed four weeks of double-blind dosing in Study TMX-00-004.
Must not have experienced any serious study drug-related Adverse Events in Study TMX 00-004.

Key exclusion criteria (6 listed)

History of xanthinuria
Alcohol consumption >14/week
Has a History of significant concomitant illness
Has active liver disease.
Has a body mass index greater than 50 kg/m2

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FebuxostatAlso: TMX-67, Tei-6720, UloricFebuxostat 40 mg, tablets, orally, once daily, based on serum urate level.	Drug	1
FebuxostatAlso: TMX-67, Tei-6720, UloricFebuxostat 80 mg, tablets, orally, once daily, based on serum urate level.	Drug	2
FebuxostatAlso: TMX-67, Tei-6720, UloricFebuxostat 120 mg, tablets, orally, once daily, based on serum urate level.	Drug	3

Primary outcome

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit.
Time frame: Month 6
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit.
Time frame: Month 12
Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized.
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit.
Time frame: Month 18
Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 18 visit was summarized.
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit.
Time frame: Month 24
Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized.
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit.
Time frame: Month 36
Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized.
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit.
Time frame: Month 48
Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 48 visit was summarized.
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit.
Time frame: Month 60
Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 60 visit was summarized.
Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit.
Time frame: Last Visit on treatment (up to 66 months).
The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.

8 secondary outcomes

Percent Change in Serum Urate Levels From Baseline at Month 6 Visit.
Time frame: Baseline and Month 6
Percent Change in Serum Urate Levels From Baseline at Month 12 Visit.
Time frame: Baseline and Month 12
Percent Change in Serum Urate Levels From Baseline at Month 18 Visit.
Time frame: Baseline and Month 18
Percent Change in Serum Urate Levels From Baseline at Month 24 Visit.
Time frame: Baseline and Month 24
Percent Change in Serum Urate Levels From Baseline at Month 36 Visit.
Time frame: Baseline and Month 36
Percent Change in Serum Urate Levels From Baseline at Month 48 Visit.
Time frame: Baseline and Month 48
Percent Change in Serum Urate Levels From Baseline at Month 60 Visit.
Time frame: Baseline and Month 60
Percent Change in Serum Urate Levels From Baseline at Final Visit.
Time frame: Baseline and Last Visit on treatment (up to 66 months).

Results and safety

Results posted to the registry on 16 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Febuxostat 40 mg QD	8	6
Febuxostat 80 mg QD	79	41
Febuxostat 120 mg QD	29	11
Total Febuxostat	116	58

Primary outcome: Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit.

Time frame: Month 6. Number. Unit: percentage of subjects

Measure	Febuxostat 40 mg QD n = 10	Febuxostat 80 mg QD n = 58	Febuxostat 120 mg QD n = 17	Total Febuxostat n = 85
Value	50	93	65	82

Population analysed: Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.

Primary outcome: Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit.

Time frame: Month 12. Number. Unit: percentage of subjects

Measure	Febuxostat 40 mg QD n = 7	Febuxostat 80 mg QD n = 55	Febuxostat 120 mg QD n = 18	Total Febuxostat n = 80
Value	57	85	67	79

Population analysed: Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.

Primary outcome: Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit.

Time frame: Month 18. Number. Unit: percentage of subjects

Measure	Febuxostat 40 mg QD n = 8	Febuxostat 80 mg QD n = 50	Febuxostat 120 mg QD n = 14	Total Febuxostat n = 72
Value	50	82	57	74

Population analysed: Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.

Primary outcome: Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit.

Time frame: Month 24. Number. Unit: percentage of subjects

Measure	Febuxostat 40 mg QD n = 8	Febuxostat 80 mg QD n = 49	Febuxostat 120 mg QD n = 13	Total Febuxostat n = 70
Value	63	76	92	77

Population analysed: Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Febuxostat 40 mg QD	3 of 12 (25%)	5 of 12 (41.7%)	Not reported
Febuxostat 80 mg QD	14 of 116 (12.1%)	44 of 116 (37.9%)	Not reported
Febuxostat 120 mg QD	4 of 37 (10.8%)	9 of 37 (24.3%)	Not reported
Febuxostat Total	21 of 116 (18.1%)	53 of 116 (45.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 16911575Colwell HH, Hunt BJ, Pasta DJ, Palo WA, Mathias SD, Joseph-Ridge N. Gout Assessment Questionnaire: Initial results of reliability, validity and responsiveness. Int J Clin Pract. 2006 Oct;60(10):1210-7. doi: 10.1111/j.1742-1241.2006.01104.x. Epub 2006 Aug 15.
Results publication: PubMed 19141576Schumacher HR Jr, Becker MA, Lloyd E, MacDonald PA, Lademacher C. Febuxostat in the treatment of gout: 5-yr findings of the FOCUS efficacy and safety study. Rheumatology (Oxford). 2009 Feb;48(2):188-94. doi: 10.1093/rheumatology/ken457.
Results publication: PubMed 21169856Whelton A, Macdonald PA, Zhao L, Hunt B, Gunawardhana L. Renal function in gout: long-term treatment effects of febuxostat. J Clin Rheumatol. 2011 Jan;17(1):7-13. doi: 10.1097/RHU.0b013e318204aab4.
Uloric Package InsertLink provided by the sponsor.

Related trials for Gout

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Tophaceous Gout
Not yet recruitingPhase 3
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The Remote Monitoring of Gout Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study chair

Takeda

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Febuxostat in people with Gout, run by Takeda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. (time frame: Month 6). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00174941, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2011.