GoutPhase 3NCT02082769

Safety and Efficacy of Oral Febuxostat in Subjects With Gout

A Phase 3 study testing Febuxostat and Allopurinol in people with Gout, run by Xijing Hospital.

Completed

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

Official record

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Trial summary

The purpose of this study is to compare febuxostat allopurinol in subjects with gout. Read more about this study

Who is it for?: Ages 18 to 70 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: 504 participants
Where: No sites listed yet
Study dates: Jul 2011to Oct 2013
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Hyperuricemia (serum urate ≥8.0 mg/dL) and gout by Chinese Rheumatism Association Criteria;
Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 milliliters per minute (mL/min) by Cockcroft and Gault formula;
No gout flare 2 weeks beforehand during 2-week screening period.

Who cannot join

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 active liver disease, or hepatic dysfunction;
A history of bronchial asthma;
A history of renal calculi or thyroid disease;

Show all 10Show fewer

Secondary gout Joint diseases induced by rheumatoid arthritis, psoriatic arthritis and bone tumor;
Intolerance to allopurinol and Ibuprofen;
Alcohol intake of ≥ 14 drinks/week;
Clinically significant medical condition.

About this study

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

The purpose of this study is to compare febuxostat allopurinol in subjects with gout.

Read the detailed description

A randomized, double-blind, multicenter, allopurinol-controlled and parallel-assigned study comparing 40 mg, 80 mg of febuxostat, and allopurinol 300 mg in subjects with gout. Subjects will receive treatment for 24 weeks.

Conditions: Gout
Being tested: Febuxostat, Allopurinol
Keywords: Gout, Uric Acid, Xanthine oxidase, Febuxostat
Medical subject headings: Gout

What participants receive

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

FebuxostatDrug
AllopurinolDrug

Study groups in NCT02082769
Study group	Role	What they receive
Febuxostat 40 mg QD	Experimental	Febuxostat 40 mg, orally, once daily for up to 24 weeks Receives: Drug: Febuxostat
Febuxostat 80 mg QD	Experimental	Febuxostat 80 mg, orally, once daily for up to 24 weeks Receives: Drug: Febuxostat
Allopurinol 100mg QD	Active comparator	Allopurinol 100mg, orally, three times daily for up to 24 weeks Receives: Drug: Allopurinol

What is being measured

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

Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)
Measured: Last 3 visits (any last 3 visits up to week 26)

Secondary outcomes (1)

Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit
Measured: Final Visit (up to 26 weeks)

Timeline

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

Jul 2011Oct 2013

First posted10 Mar 2014 (estimated)
Study startJul 2011
Primary completionOct 2013
Study completionOct 2013

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 (1)Papers the sponsor has linked to this study.
Other trials for GoutStudies of the same condition, open and under way.
More trials run by Xijing HospitalThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 504 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02082769
Sponsor's protocol ID: SFDA2010L04287
Status last verified: Mar 2014
First submitted: 6 Mar 2014
Last updated: 3 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Xu S, Liu X, Ming J, Chen S, Wang Y, Liu X, Liu H, Peng Y, Wang J, Lin J, Ji H, Liu B, Lu Y, Liu P, Zhang Y, Ji Q. A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia. Int J Rheum Dis. 2015 Jul;18(6):669-78. doi: 10.1111/1756-185X.12648. Epub 2015 May 27.
PubMed 26013187

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 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Multicenter, Allopurinol-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout
ClinicalTrials.gov ID: NCT02082769
Acronym / sponsor ID: SFDA2010L04287
Conditions: Gout
Keywords: Gout, Uric Acid, Xanthine oxidase, Febuxostat
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 504 participants (actual)
Lead sponsor: Xijing HospitalUniversity, hospital or other
Collaborators: Qingdao Shengbang Pharmaceutical Co., Ltd.
Study start: Jul 2011
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 10 Mar 2014 (estimated)
Results: Posted 3 Feb 2016

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 compare febuxostat allopurinol in subjects with gout.

Detailed description

Study design

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

Arm	Type	Receives
Febuxostat 40 mg QD	Experimental	Drug: FebuxostatFebuxostat 40 mg, orally, once daily for up to 24 weeks
Febuxostat 80 mg QD	Experimental	Drug: FebuxostatFebuxostat 80 mg, orally, once daily for up to 24 weeks
Allopurinol 100mg QD	Active comparator	Drug: AllopurinolAllopurinol 100mg, orally, three times daily for up to 24 weeks

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Hyperuricemia (serum urate ≥8.0 mg/dL) and gout by Chinese Rheumatism Association Criteria;
Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 milliliters per minute (mL/min) by Cockcroft and Gault formula;
No gout flare 2 weeks beforehand during 2-week screening period.

Key exclusion criteria (10 listed)

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 active liver disease, or hepatic dysfunction;
A history of bronchial asthma;

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
Febuxostat	Drug	Febuxostat 40 mg QD, Febuxostat 80 mg QD
Allopurinol	Drug	Allopurinol 100mg QD

Primary outcome

Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)
Time frame: Last 3 visits (any last 3 visits up to week 26)

1 secondary outcome

Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit
Time frame: Final Visit (up to 26 weeks)

Results and safety

Results posted to the registry on 3 Feb 2016, 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	168	144
Febuxostat 80 mg QD	168	141
Allopurinol 100mg QD	168	132

Primary outcome: Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)

Time frame: Last 3 visits (any last 3 visits up to week 26). Number. Unit: percentage of participants

Measure	Febuxostat 40 mg QD n = 160	Febuxostat 80 mg QD n = 158	Allopurinol 100mg QD n = 159
Value	22.5	33.5	17.0

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Febuxostat 40 mg QD	0 of 168 (0%)	45 of 168 (26.8%)	Not reported
Febuxostat 80 mg QD	1 of 168 (0.6%)	46 of 168 (27.4%)	Not reported
Allopurinol 100mg QD	0 of 168 (0%)	41 of 168 (24.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26013187Xu S, Liu X, Ming J, Chen S, Wang Y, Liu X, Liu H, Peng Y, Wang J, Lin J, Ji H, Liu B, Lu Y, Liu P, Zhang Y, Ji Q. A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia. Int J Rheum Dis. 2015 Jul;18(6):669-78. doi: 10.1111/1756-185X.12648. Epub 2015 May 27.

Related trials for Gout

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

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.

Shenren Chen, M.D. principal investigator

Second Affiliated Hospital of Shantou University Medical College

Yangang Wang, M.D. principal investigator

The Affiliated Hospital of Qingdao University

Xiumei Liu, M.D. principal investigator

The First Affiliated Hospital of Shanxi Medical University

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Febuxostat and Allopurinol in people with Gout, run by Xijing Hospital.

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 3 inclusion and 10 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 3 Feb 2016. 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 3 Feb 2016). 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 Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL) (time frame: Last 3 visits (any last 3 visits up to week 26)). 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 NCT02082769, which also lists 1 linked publication.

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 3 Feb 2016.