Skip to main content
OpenTrials
Completed

NCT Number: NCT00102440

Febuxostat Versus Allopurinol Control Trial 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Febuxostat

Drug

Febuxostat 80 mg, orally, once daily for up to 52 weeks.

Other names: TMX-67, Tei-6720, Uloric

Allopurinol

Drug

Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit

    Time frame: Week 28

    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.

  2. Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit

    Time frame: Week 52

    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.

  3. Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit

    Time frame: Final Visit (up to 52 weeks)

    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.

  4. Percent Change From Baseline in Serum Urate Levels at Week 28.

    Time frame: Baseline and 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.

  5. Percent Change From Baseline in Serum Urate Levels at Week 52.

    Time frame: Baseline and 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.

  6. Percent Change From Baseline in Serum Urate Levels at Final Visit

    Time frame: Baseline and Final Visit (up to 52 weeks)

    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.

  7. 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

    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.

  8. 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

    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.

  9. 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)

    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.

  10. Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.

    Time frame: Baseline and Week 28

    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.

  11. Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.

    Time frame: Baseline and Week 52

    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.

  12. 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)

    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.

  13. Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.

    Time frame: Weeks 8 through 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Acronym: FACT

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Jan 31, 2005
Registry last updated
Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.