GoutPhase 3NCT01736514
A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout
A Phase 3 study testing febuxostat and Allopurinol in people with Gout, run by Astellas Pharma Taiwan, Inc. at 4 sites in Taiwan.
Trial summary
This is a multicenter, open label, randomized, allopurinol-controlled, parallel-design study. Approximately 120 subjects will be randomly assigned in 1:1 ratio to receive febuxostat, or allopurinol for subjects with gout. Read more about this study
- Who is it for?
- Ages 20 to 65 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
- 109 participants
- Where
- 4 sitesTaiwan
- Study dates
- Mar 2011to Feb 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will also have a history or presence of gout as defined by the American College of Rheumatology (ACR) criteria
- Subject has serum urate level >= 8.0 mg/dL at the screening Visit
Who cannot join
- Female subject who is breast-feeding or pregnant
- Subject has a history of xanthinuria
- Subject who is intolerant of allopurinol, ie hypersensitivity, Steven-Johnson syndrome/topic epidermal necrolysis
- Subject who takes allopurinol > 300 mg/day and with serum urate level > 8mg/dL
- Subject who is HLA B*5801 positive
- Subject who is receiving thiazide diuretic therapy
Show all 15Show fewer
- Subject who has secondary hyperuricemia
- Subject who requires concurrent therapy with any systemic or topical medications, prescribed or non-prescribed, containing aspirin or other salicylates (low doses of aspirin will be allowed(ie. =< 325mg/day)
- Subject who requires therapy with prednisone > 10 mg/ day during the study
- Subject who has active liver disease or hepatic dysfunction, defined as both ALT and AST > 1.5 times the upper limit of normal
- Subject who has serum creatinine >= 1.5mg/dL
- Subject who has any another significant medical condition as defined by the investigator that would interfere with the treatment, safety or compliance with the protocol (eg. A clinically significant ECG result)
- Subject who has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the study, or has taken any systemic cancer chemotherapy within 5 years prior to the study
- Subject who has previously participated in a clinical study in which febuxostat was administered
- Subject who has participated in another investigational trial within the 30 days prior to the study
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Study site
Kaohsiung City
Study site
Linkou District
Study site
Taichung
Study site
Taipei
About this study
Official title: A Randomized, Open Label, Multicenter, Allopurinol- Controlled Study to Assess the Safety and Efficacy of Oral Febuxostat in Patients With Gout
This is a multicenter, open label, randomized, allopurinol-controlled, parallel-design study. Approximately 120 subjects will be randomly assigned in 1:1 ratio to receive febuxostat, or allopurinol for subjects with gout.
- Conditions
- Gout
- Being tested
- febuxostat, Allopurinol
- Keywords
- xanthine oxidase inhibitor, Uric acid lowering drug
- 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 Adenuric, Uloric, Feburic
oral
AllopurinolDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| febuxostat group | Experimental | oral Receives: Drug: febuxostat |
| allopurinol group | Active comparator | oral Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL
Measured: week 12
Secondary outcomes (2)
Percent reduction in serum urate levels
Measured: Baseline and at week 12
Safety assessed by the incidence of adverse events, physical exam. and vital signs, tabo-tests and 12-lead ECG
Measured: Baseline and at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startMar 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Taiwan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Taiwan, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736514
- Sponsor's protocol ID
- TMXALL-1001-TW
- Status last verified
- Oct 2014
- First submitted
- 27 Nov 2012
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multicenter, Allopurinol- Controlled Study to Assess the Safety and Efficacy of Oral Febuxostat in Patients With Gout
- ClinicalTrials.gov ID
- NCT01736514
- Acronym / sponsor ID
- TMXALL-1001-TW
- Conditions
- Gout
- Keywords
- xanthine oxidase inhibitor, Uric acid lowering drug
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Astellas Pharma Taiwan, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open label, randomized, allopurinol-controlled, parallel-design study. Approximately 120 subjects will be randomly assigned in 1:1 ratio to receive febuxostat, or allopurinol for subjects with gout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| febuxostat group | Experimental | Drug: febuxostatoral |
| allopurinol group | Active comparator | Drug: Allopurinoloral |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects will also have a history or presence of gout as defined by the American College of Rheumatology (ACR) criteria
- Subject has serum urate level >= 8.0 mg/dL at the screening Visit
Key exclusion criteria (15 listed)
- Female subject who is breast-feeding or pregnant
- Subject has a history of xanthinuria
- Subject who is intolerant of allopurinol, ie hypersensitivity, Steven-Johnson syndrome/topic epidermal necrolysis
- Subject who takes allopurinol > 300 mg/day and with serum urate level > 8mg/dL
- Subject who is HLA B*5801 positive
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: Adenuric, Uloric, Feburicoral | Drug | febuxostat group |
| Allopurinoloral | Drug | allopurinol group |
Primary outcome
Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL
Time frame: week 12
2 secondary outcomes
Percent reduction in serum urate levels
Time frame: Baseline and at week 12
Safety assessed by the incidence of adverse events, physical exam. and vital signs, tabo-tests and 12-lead ECG
Time frame: Baseline and at week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
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.
Medical Director study director
Astellas Pharma Taiwan, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing febuxostat and Allopurinol in people with Gout, run by Astellas Pharma Taiwan, Inc. at 4 sites in Taiwan.
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 15 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 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2014.