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Completed

NCT Number: NCT00430248

Efficacy and Safety of Oral Febuxostat in Participants With Gout

The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Hyperuricemia Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

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About this study

Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to 70%. This population represents an unmet medical need as uricosuric drugs are contraindicated in these patients, and the only available treatment, allopurinol, may have to be dose reduced to avoid overt side effects.

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.

Treatment duration will be 6 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has one or more of the American Rheumatism Association criteria for the diagnosis of gout.
  • 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.
  • Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).

Exclusion criteria

  • Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study.
  • Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation.
  • History of xanthinuria.
  • Alcohol consumption greater than 14/week.
  • History of significant concomitant illness.
  • Active liver or peptic ulcer disease.
  • Has rheumatoid arthritis requiring treatment.
  • Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight.
  • Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.

Treatment and study plan

Febuxostat

Drug

Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.

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

Allopurinol

Drug

Allopurinol 200 mg or 300 mg, capsules, orally, once daily for up to 6 months.

Dose is dependent on the subject's renal function. Subjects with normal renal function or mild renal impairment received 300 mg once daily; subjects with moderate renal impairment received 200 mg once daily.

Other names: Zyloprim

Primary outcomes

  1. Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.

    Time frame: Last Visit on treatment (up to 6 months)

    The percentage of subjects whose serum urate level 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.

Secondary outcomes

  1. Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl

    Time frame: Last Visit on treatment (up to 6 months)

    The percentage of subjects with mild-to-moderate renal impairment 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.

  2. Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.

    Time frame: Month 2

    Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 2 visit was summarized.

  3. Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.

    Time frame: Month 4

    Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 4 visit was summarized.

  4. Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.

    Time frame: Month 6

    Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.

  5. Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.

    Time frame: Month 2

    Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 2 visit was summarized.

  6. Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.

    Time frame: Month 4

    Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 4 visit was summarized.

  7. Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.

    Time frame: Month 6

    Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 6 visit was summarized.

  8. Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.

    Time frame: Last Visit on treatment (up to 6 months)

    The percentage of subjects whose serum urate level was <5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.

  9. Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit

    Time frame: Month 2

    Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 2 visit was summarized.

  10. Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit

    Time frame: Month 4

    Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 4 visit was summarized.

  11. Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit

    Time frame: Month 6

    Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 6 visit was summarized.

  12. Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit

    Time frame: Last Visit on treatment (up to 6 months)

    The percentage of subjects whose serum urate level was <4.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.

  13. Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.

    Time frame: Baseline and Month 2

    Serum urate values were obtained at the Month 2 visit. The percent change in serum urate from baseline to the Month 2 visit was summarized.

  14. Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit

    Time frame: Baseline and Month 4

    Serum urate values were obtained at the Month 4 visit. The percent change in serum urate from baseline to the Month 4 visit was summarized.

  15. Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.

    Time frame: Baseline and Month 6

    Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.

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

    Time frame: Baseline and Last Visit on treatment (up to 6 months)

    The percent change in serum urate from baseline to the Final visit was summarized. The final visit was the last visit at which a serum urate value was collected.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout.

Acronym: CONFIRMS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 1, 2007
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.

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