GoutPhase 3NCT00821392
Phase III Trial of Febuxostat in Korea Gout Patients
A Phase 3 study testing Febuxostat in people with Gout, run by SK Chemicals Co., Ltd..
Trial summary
This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Sep 2007
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- <Day -14>
- age :18-85 years
- female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception
- female: negative serum pregnancy test
- subjects who satisfy ARA (American Rheumatism Association)
- subjects must have a renal function defined as: serum creatinine ≤ 1.5 mg/dL <Day -1>
- 1.serum urate level ≥8.0mg/dL 2.creatinine level ≤ 1.5mg/dL 3.subject continued to meet all inclusion and no exclusion criteria
Who cannot join
- women who are breast-feeding or pregnant
- a history of xanthinuria
- allopurinol intolerance
- receiving thiazide diuretic therapy
- secondary hyperuricemia
- required > 10mg/day of prednisone during the study stable dose(≤10mg/day), inhaled and intranasal steroids will be allowed.
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- concomitant therapy containing aspirin or other salicylates(systemic or topical, prescribed or non-prescribed) stable, low doses aspirin will be allowed(i.e. ≤325mg/day).
- any change in hormone replacement therapy or oral contraceptive therapy within 3 months of the screening visit
- alcohol intake≥ 14drinks/week alcohol abuse within 5 years or current excessive alcohol use was prohibited.
- concomitant therapy with any urate-lowering therapy
- active liver disease or hepatic dysfunction : ALT, AST ≥1.5 ULN
- subject was unable to take colchicine or contradictory to colchicine
- a serum urate level < 8.0mg/dL and not taking uric acid lowering therapy
- rheumatoid arthritis or any active arthritis requiring for the medication treatment
- a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the screening visit, or had taken any systemic cancer chemotherapy within 5 years prior to the screening visit
- participated in another investigational trial within the 30days prior to the screening visit
- any other significant medical condition as defined by the investigator
About this study
Official title: A Randomized, Multi-Center, Double Blinded, Allopurinol-Controlled, Placebo-Controlled Parallel Group, 5-Arm, Dose-Response,Bridging Study to Assess the Efficacy and Safety of Febuxostat in Subject With Gout
This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea
Read the detailed description
This is a multi-center, randomized, double-blind, allopurinol and placebo controlled, parallel, 5 arms, dose response, bridging study of 4 weeks duration.
If subjects pass the screening evaluation after submitting a signed informed consent, they will be randomly assigned to one of the five treatment regimens; febuxostat 40mg, 80mg, 120mg, placebo or allopurinol 300mg. Colchicine 0.6mg QDis given to minimize the risk of gout flares during the washout/run-in period and during the double study period.
- Conditions
- Gout
- Being tested
- 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
| Study group | Role | What they receive |
|---|---|---|
| 1 Febuxostat 40mg | Active comparator | Not described Receives: Drug: Febuxostat |
| 2 Febuxostat 80mg | Active comparator | Not described Receives: Drug: Febuxostat |
| 3 Febuxostat 120mg | Active comparator | Not described Receives: Drug: Febuxostat |
| 4 Allopurinol 300mg | Sham comparator | Not described Receives: Drug: Febuxostat |
| 5 Placebo | Placebo comparator | Not described Receives: Drug: Febuxostat |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startAug 2006
- Primary completionSep 2007
- Study completionSep 2007
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821392
- Sponsor's protocol ID
- TMX-67
- Status last verified
- Oct 2007
- First submitted
- 12 Jan 2009
- Last updated
- 13 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center, Double Blinded, Allopurinol-Controlled, Placebo-Controlled Parallel Group, 5-Arm, Dose-Response,Bridging Study to Assess the Efficacy and Safety of Febuxostat in Subject With Gout
- ClinicalTrials.gov ID
- NCT00821392
- Acronym / sponsor ID
- TMX-67
- Conditions
- Gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 13 Jan 2009 (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 study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea
Detailed description
This is a multi-center, randomized, double-blind, allopurinol and placebo controlled, parallel, 5 arms, dose response, bridging study of 4 weeks duration.
If subjects pass the screening evaluation after submitting a signed informed consent, they will be randomly assigned to one of the five treatment regimens; febuxostat 40mg, 80mg, 120mg, placebo or allopurinol 300mg. Colchicine 0.6mg QDis given to minimize the risk of gout flares during the washout/run-in period and during the double study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 Febuxostat 40mg | Active comparator | Drug: Febuxostat |
| 2 Febuxostat 80mg | Active comparator | Drug: Febuxostat |
| 3 Febuxostat 120mg | Active comparator | Drug: Febuxostat |
| 4 Allopurinol 300mg | Sham comparator | Drug: Febuxostat |
| 5 Placebo | Placebo comparator | Drug: Febuxostat |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- <Day -14>
- age :18-85 years
- female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception
- female: negative serum pregnancy test
- subjects who satisfy ARA (American Rheumatism Association)
Key exclusion criteria (17 listed)
- women who are breast-feeding or pregnant
- a history of xanthinuria
- allopurinol intolerance
- receiving thiazide diuretic therapy
- secondary hyperuricemia
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 | 1 Febuxostat 40mg, 2 Febuxostat 80mg, 3 Febuxostat 120mg, 4 Allopurinol 300mg, 5 Placebo |
Primary outcome
Not reported in the source record.
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 13 Jan 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Febuxostat in people with Gout, run by SK Chemicals Co., Ltd..
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 7 inclusion and 17 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 13 Jan 2009. 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. Some participants in this study may receive a placebo. 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.
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 13 Jan 2009.