Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00430248
First received: January 25, 2007
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Gout
 Drug: Febuxostat
Drug: Allopurinol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

MedlinePlus related topics: Gout
U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit. [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit. [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit. [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit. [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit. [ Time Frame: Baseline and Month 2 ] [ Designated as safety issue: No ]
    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.

  • Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit [ Time Frame: Baseline and Month 4 ] [ Designated as safety issue: No ]
    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.

  • Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit. [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Percent Change From Baseline in Serum Urate Levels at Final Visit. [ Time Frame: Baseline and Last Visit on treatment (up to 6 months) ] [ Designated as safety issue: No ]
    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.


Enrollment: 2269
Study Start Date: February 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430248

  Show 258 Study Locations
Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
Study Chair: Medical Director Takeda Global Research & Development Center, Inc.
  More Information

Additional Information:
Uloric Package Insert  This link exits the ClinicalTrials.gov site
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

Publications:

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

Responsible Party: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00430248     History of Changes
Other Study ID Numbers: F-GT06-153, U1111-1114-0226
Study First Received: January 25, 2007
Results First Received: March 12, 2009
Last Updated: January 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:
tophi
hyperuricemia
uric acid
Drug Therapy

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
Febuxostat
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013