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GoutPhase 2NCT00174967

Dose-Response, Safety and Efficacy 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.

Official record
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Trial summary

The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate 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?
Yes, some participants may receive a placebo
How many people
153 participants
Where
No sites listed yet
Study dates
Jan 2001to Jul 2001
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).
  • Must meet American College of Rheumatology criteria for gout.
  • Must have adequate renal function (serum creatinine <1.5 mg/dL).
  • 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 kilogram per meter² (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, Dose-Response, Safety and Efficacy Study of Oral TMX-67 in Subjects With Gout.

The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.

Read the detailed description

Gout is a chronic urate crystal deposition disorder, which if left untreated may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate concentration of >7.0 milligrams per deciliter (mg/dL), is the underlying metabolic aberration leading to urate crystal deposition in gout. Gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis. As serum urate levels increase beyond >7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.

Currently allopurinol is the only xanthine oxidase inhibitor available. Allopurinol is the agent of choice for reduction of serum urate levels in patients with: uric acid overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function; uric acid urolithiasis; or tophi.

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.

Conditions
Gout
Being tested
Placebo, 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.

  • PlaceboDrug

    Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks.

  • FebuxostatDrug

    Also called TMX-67, Tei-6720, Uloric

    Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.

  • FebuxostatDrug

    Also called TMX-67, Tei-6720, Uloric

    Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.

  • FebuxostatDrug

    Also called TMX-67, Tei-6720, Uloric

    Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.

Study groups in NCT00174967
Study groupRoleWhat they receive
Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo
Febuxostat 40 mg QDExperimentalNot described
Receives: Drug: Febuxostat
Febuxostat 80 mg QDExperimentalNot described
Receives: Drug: Febuxostat
Febuxostat 120 mg QDExperimentalNot described
Receives: Drug: Febuxostat

What is being measured

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

  1. Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.

    Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 28 visit was summarized.

    Measured: Day 28.

Secondary outcomes (9)

  1. Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.

    Serum urate values were obtained at the Day 7 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 7 visit was summarized.

    Measured: Day 7.

  2. Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.

    Serum urate values were obtained at the Day 14 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 14 visit was summarized.

    Measured: Day 14.

  3. Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.

    Serum urate values were obtained at the Day 21 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 21 visit was summarized.

    Measured: Day 21.

  4. Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.

    Serum urate values were obtained at the Day 7 visit. The percent change in serum urate from baseline to the Day 7 visit was summarized.

    Measured: Baseline and Day 7.

  5. Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.

    Serum urate values were obtained at the Day 14 visit. The percent change in serum urate from baseline to the Day 14 visit was summarized.

    Measured: Baseline and Day 14.

  6. Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit

    Serum urate values were obtained at the Day 21 visit. The percent change in serum urate from baseline to the Day 21 visit was summarized.

    Measured: Baseline and Day 21.

  7. Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.

    Serum urate values were obtained at the Day 28 visit. The percent change in serum urate from baseline to the Day 28 visit was summarized.

    Measured: Baseline and Day 28.

  8. Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.

    Serum urate values were obtained at the Day 7, 14, 21,and 28 visits. The maximum percent change in serum urate levels obtained at any visit was summarized.

    Measured: Baseline and Any visit (Day 7, 14, 21,or 28)

  9. Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.

    24-hour urine uric acid levels were obtained at the Day 28 visit. The percent change in 24-hour urine uric acid level from baseline to the Day 28 visit was summarized.

    Measured: Baseline and Day 28.

Timeline

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

  1. First posted15 Sep 2005 (estimated)
  2. Study startJan 2001
  3. Primary completionJul 2001
  4. Study completionJul 2001

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00174967
Sponsor's protocol ID
TMX-00-004
Other IDs
U1111-1114-1992
Status last verified
Jul 2011
First submitted
9 Sep 2005
Last updated
29 Jul 2011
Data monitoring committee
No

Publications

  • Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Palo WA, Eustace D, Vernillet L, Joseph-Ridge N. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twenty-eight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum. 2005 Mar;52(3):916-23. doi: 10.1002/art.20935.

    PubMed 15751090

  • 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

  • Goldfarb DS, MacDonald PA, Hunt B, Gunawardhana L. Febuxostat in gout: serum urate response in uric acid overproducers and underexcretors. J Rheumatol. 2011 Jul;38(7):1385-9. doi: 10.3899/jrheum.101156. Epub 2011 May 15.

    PubMed 21572152

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 4 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 29 Jul 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. 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 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 Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit. (time frame: Day 28.). 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 NCT00174967, 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 29 Jul 2011.

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