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Efficacy and Safety of Oral Febuxostat in Participants With Gout (CONFIRMS)

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ClinicalTrials.gov Identifier: NCT00430248
Recruitment Status : Completed
First Posted : February 1, 2007
Results First Posted : July 16, 2009
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gout Drug: Febuxostat Drug: Allopurinol Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout.
Study Start Date : February 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arms and Interventions
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Arm Intervention/treatment
Experimental: Febuxostat 40 mg QD Drug: Febuxostat
Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.
Other Names:
  • TMX-67
  • Tei-6720
  • Uloric
Experimental: Febuxostat 80 mg QD Drug: Febuxostat
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
Other Names:
  • TMX-67
  • Tei-6720
  • Uloric
Active Comparator: Allopurinol 200 mg or 300 mg QD
(dependent on renal function)
 Drug: Allopurinol

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 Name: Zyloprim


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430248


Locations
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Sponsors and Collaborators
Takeda
Investigators
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Study Chair: Medical Director Takeda
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00430248    
Other Study ID Numbers: F-GT06-153
U1111-1114-0226 ( Registry Identifier: WHO )
First Posted: February 1, 2007    Key Record Dates
Results First Posted: July 16, 2009
Last Update Posted: February 2, 2012
Last Verified: January 2012
Keywords provided by Takeda:
tophi
hyperuricemia
uric acid
Drug Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
 Febuxostat
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs