GoutPhase 3FACTNCT00102440

Febuxostat Versus Allopurinol Control Trial in Subjects With Gout

A Phase 3 study testing Febuxostat and Allopurinol 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 safety and efficacy of febuxostat, once daily (QD), versus allopurinol 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 and Allopurinol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 760 participants
Where: No sites listed yet
Study dates: Jul 2002to Feb 2004
Phase: Phase 3
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

Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline

Who cannot join

Serum creatinine >1.5 mg/dL
Calculated creatinine clearance of <50 milliliters per minutes (mL/min)
Pregnancy or lactation;
Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;
Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);
A history of xanthinuria, active liver disease, or hepatic dysfunction;
A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.

About this study

Official title: A Phase 3, Randomized, Multicenter Study Comparing the Safety and Efficacy of Oral Febuxostat Versus Allopurinol in Subjects With Gout

The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.

Read the detailed description

This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization. Subjects were then randomized to one of three treatment groups: febuxostat 80 milligram (mg), febuxostat 120 mg, or allopurinol 300 mg. Naproxen (250 mg twice daily) or colchicine (0.6 mg once daily) was provided for prophylaxis of acute gout flares during the washout period and the first 8 weeks of double-blind treatment.

Conditions: Gout
Being tested: Febuxostat, Allopurinol
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 80 mg, orally, once daily for up to 52 weeks.
FebuxostatDrug
Also called TMX-67, Tei-6720, Uloric
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
AllopurinolDrug
Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.

Study groups in NCT00102440
Study group	Role	What they receive
Febuxostat 80 mg QD	Experimental	Not described Receives: Drug: Febuxostat
Febuxostat 120 mg QD	Experimental	Not described Receives: Drug: Febuxostat
Allopurinol 300 mg QD	Active comparator	Not described Receives: Drug: Allopurinol

What is being measured

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

Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)
Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.
Measured: Last 3 Visits (up to 52 weeks)

Secondary outcomes (13)

Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit
Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized.
Measured: Week 28
Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit
Serum urate values were obtained at the Week 52 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 52 visit was summarized.
Measured: Week 52
Percentage of Subjects With Serum Urate <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. The timing of the final visit may have differed for each subject.
Measured: Final Visit (up to 52 weeks)
Percent Change From Baseline in Serum Urate Levels at Week 28.
Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(week 28 - baseline levels/baseline)]*100 and summarized.
Measured: Baseline and Week 28
Percent Change From Baseline in Serum Urate Levels at Week 52.
Serum urate values were obtained at the Week 52 visit. The percent change in serum urate was calculated as [(week 52 - baseline levels/baseline)]*100 and summarized.
Measured: Baseline and Week 52
Percent Change From Baseline in Serum Urate Levels at Final Visit
The percent change in serum urate from baseline to the Final visit was calculated as [(Final Visit - baseline levels/baseline)]*100 and summarized. The Final visit was the last visit with a serum urate value. The timing of the final visit may have differed for each subject.
Measured: Baseline and Final Visit (up to 52 weeks)
Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero.
Measured: Baseline and Week 28
Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 52 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 52 visit, the size was assumed to be zero.
Measured: Baseline and Week 52
Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject.
Measured: Baseline and Final Visit (up to 52 weeks)
Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.
The change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 28 visit, the total count was assumed to be zero.
Measured: Baseline and Week 28
Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.
The change from baseline at Week 52 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 52 visit, the total count was assumed to be zero.
Measured: Baseline and Week 52
Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.
Change in number of tophi/subject calculated for the subset of subjects with palpable tophi at Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject.
Measured: Baseline and Final Visit (up to 52 weeks)
Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.
The percentage of subjects requiring treatment for a gout flare between Weeks 8 and 52 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.
Measured: Weeks 8 through 52

Timeline

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

Jul 2002Feb 2004

First posted31 Jan 2005 (estimated)
Study startJul 2002
Primary completionFeb 2004
Study completionFeb 2004

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 (4)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 760 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00102440
Sponsor's protocol ID: C02-010
Other IDs: U1111-1114-0184
Acronym: FACT
Status last verified: Jan 2012
First submitted: 29 Jan 2005
Last updated: 2 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Eustace D, Palo WA, Streit J, Joseph-Ridge N. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005 Dec 8;353(23):2450-61. doi: 10.1056/NEJMoa050373.
PubMed 16339094
Becker MA, MacDonald PA, Hunt BJ, Lademacher C, Joseph-Ridge N. Determinants of the clinical outcomes of gout during the first year of urate-lowering therapy. Nucleosides Nucleotides Nucleic Acids. 2008 Jun;27(6):585-91. doi: 10.1080/15257770802136032.
PubMed 18600509
Wortmann RL, Macdonald PA, Hunt B, Jackson RL. Effect of prophylaxis on gout flares after the initiation of urate-lowering therapy: analysis of data from three phase III trials. Clin Ther. 2010 Dec;32(14):2386-97. doi: 10.1016/j.clinthera.2011.01.008.
PubMed 21353107
Chohan S, Becker MA, MacDonald PA, Chefo S, Jackson RL. Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. Arthritis Care Res (Hoboken). 2012 Feb;64(2):256-61. doi: 10.1002/acr.20680.
PubMed 22052584

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 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Multicenter Study Comparing the Safety and Efficacy of Oral Febuxostat Versus Allopurinol in Subjects With Gout
ClinicalTrials.gov ID: NCT00102440
Acronym / sponsor ID: FACT / C02-010
Conditions: Gout
Keywords: uric Acid, xanthine oxidase, tophi, Drug Therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 760 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jul 2002
Primary completion: Feb 2004 (actual)
Study completion: Feb 2004 (actual)
First posted: 31 Jan 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 safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Febuxostat 80 mg QD	Experimental	Drug: Febuxostat
Febuxostat 120 mg QD	Experimental	Drug: Febuxostat
Allopurinol 300 mg QD	Active comparator	Drug: Allopurinol

Who may qualify

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

Key inclusion criteria (2 listed)

Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline

Key exclusion criteria (7 listed)

Serum creatinine >1.5 mg/dL
Calculated creatinine clearance of <50 milliliters per minutes (mL/min)
Pregnancy or lactation;
Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;
Body Mass Index (BMI) >50 kilogram per meter²(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 80 mg, orally, once daily for up to 52 weeks.	Drug	Febuxostat 80 mg QD
FebuxostatAlso: TMX-67, Tei-6720, UloricFebuxostat 120 mg, orally, once daily for up to 52 weeks.	Drug	Febuxostat 120 mg QD
AllopurinolAllopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.	Drug	Allopurinol 300 mg QD

Primary outcome

Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)
Time frame: Last 3 Visits (up to 52 weeks)
Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.

13 secondary outcomes

Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit
Time frame: Week 28
Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit
Time frame: Week 52
Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit
Time frame: Final Visit (up to 52 weeks)
Percent Change From Baseline in Serum Urate Levels at Week 28.
Time frame: Baseline and Week 28
Percent Change From Baseline in Serum Urate Levels at Week 52.
Time frame: Baseline and Week 52
Percent Change From Baseline in Serum Urate Levels at Final Visit
Time frame: Baseline and Final Visit (up to 52 weeks)
Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
Time frame: Baseline and Week 28
Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
Time frame: Baseline and Week 52
Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
Time frame: Baseline and Final Visit (up to 52 weeks)
Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.
Time frame: Baseline and Week 28
Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.
Time frame: Baseline and Week 52
Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.
Time frame: Baseline and Final Visit (up to 52 weeks)
Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.
Time frame: Weeks 8 through 52

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 80 mg QD	256	168
Febuxostat 120 mg QD	251	153
Allopurinol 300 mg QD	253	187

Primary outcome: Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)

Time frame: Last 3 Visits (up to 52 weeks). Number. Unit: Percentage of subjects

Measure	Febuxostat 80 mg QD n = 255	Febuxostat 120 mg QD n = 250	Allopurinol 300 mg QD n = 251
Value	53	62	21

Febuxostat 80 mg QD vs Allopurinol 300 mg QD: Difference in percentage: 32 (97.5% CI 23.1 to 41.3)
Febuxostat 120 mg QD vs Allopurinol 300 mg QD: Difference in percentage: 41 (97.5% CI 31.5 to 49.5)
Febuxostat 80 mg QD vs Allopurinol 300 mg QD: p <0.001, Fisher Exact

Population analysed: Analysis was performed on the intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Febuxostat 80 mg QD	10 of 256 (3.9%)	164 of 256 (64.1%)	Not reported
Febuxostat 120 mg QD	19 of 251 (7.6%)	145 of 251 (57.8%)	Not reported
Allopurinol 300 mg QD	18 of 253 (7.1%)	167 of 253 (66%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 16339094Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Eustace D, Palo WA, Streit J, Joseph-Ridge N. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005 Dec 8;353(23):2450-61. doi: 10.1056/NEJMoa050373.
Results publication: PubMed 18600509Becker MA, MacDonald PA, Hunt BJ, Lademacher C, Joseph-Ridge N. Determinants of the clinical outcomes of gout during the first year of urate-lowering therapy. Nucleosides Nucleotides Nucleic Acids. 2008 Jun;27(6):585-91. doi: 10.1080/15257770802136032.
Results publication: PubMed 21353107Wortmann RL, Macdonald PA, Hunt B, Jackson RL. Effect of prophylaxis on gout flares after the initiation of urate-lowering therapy: analysis of data from three phase III trials. Clin Ther. 2010 Dec;32(14):2386-97. doi: 10.1016/j.clinthera.2011.01.008.
Results publication: PubMed 22052584Chohan S, Becker MA, MacDonald PA, Chefo S, Jackson RL. Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. Arthritis Care Res (Hoboken). 2012 Feb;64(2):256-61. doi: 10.1002/acr.20680.
American College of RheumatologyLink provided by the sponsor.
Uloric Package InsertLink provided by the sponsor.

Related trials for Gout

RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
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RecruitingPhase 3
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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 director

Takeda

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Febuxostat and Allopurinol 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 2 inclusion and 7 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 2 Feb 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL) (time frame: Last 3 Visits (up to 52 weeks)). 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 NCT00102440, which also lists 4 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 2 Feb 2012.