Long-Term Safety of Febuxostat in Subjects With Gout. (FOCUS)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00174941
First received: September 12, 2005
Last updated: January 25, 2011
Last verified: January 2011

September 12, 2005
January 25, 2011
March 2001
December 2006   (final data collection date for primary outcome measure)
  • Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <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 Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized.
  • Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit. [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 18 visit was summarized.
  • Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit. [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized.
  • Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit. [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized.
  • Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit. [ Time Frame: Month 48 ] [ Designated as safety issue: No ]
    Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 48 visit was summarized.
  • Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit. [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 60 visit was summarized.
  • Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit. [ Time Frame: Last Visit on treatment (up to 66 months). ] [ Designated as safety issue: No ]
    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.
Number of subjects decreasing to or maintaining a serum uric acid of <6.0mg/dL at the final visit.
Complete list of historical versions of study NCT00174941 on ClinicalTrials.gov Archive Site
  • Percent Change in Serum Urate Levels From Baseline 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.
  • Percent Change in Serum Urate Levels From Baseline at Month 12 Visit. [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    Serum urate values were obtained at the Month 12 visit. The percent change in serum urate from baseline to the Month 12 visit was summarized.
  • Percent Change in Serum Urate Levels From Baseline at Month 18 Visit. [ Time Frame: Baseline and Month 18 ] [ Designated as safety issue: No ]
    Serum urate values were obtained at the Month 18 visit. The percent change in serum urate from baseline to the Month 18 visit was summarized.
  • Percent Change in Serum Urate Levels From Baseline at Month 24 Visit. [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
    Serum urate values were obtained at the Month 24 visit. The percent change in serum urate from baseline to the Month 24 visit was summarized.
  • Percent Change in Serum Urate Levels From Baseline at Month 36 Visit. [ Time Frame: Baseline and Month 36 ] [ Designated as safety issue: No ]
    Serum urate values were obtained at the Month 36 visit. The percent change in serum urate from baseline to the Month 36 visit was summarized.
  • Percent Change in Serum Urate Levels From Baseline at Month 48 Visit. [ Time Frame: Baseline and Month 48 ] [ Designated as safety issue: No ]
    Serum urate values were obtained at the Month 48 visit. The percent change in serum urate from baseline to the Month 48 visit was summarized.
  • Percent Change in Serum Urate Levels From Baseline at Month 60 Visit. [ Time Frame: Baseline and Month 60 ] [ Designated as safety issue: No ]
    The secondary outcome was the mean percent change from baseline to Month 60 visit as assessed by serum urate levels collected at baseline and at the Month 60 visit by dose at observation.
  • Percent Change in Serum Urate Levels From Baseline at Final Visit. [ Time Frame: Baseline and Last Visit on treatment (up to 66 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.
Percent reduction in serum urate levels from baseline, number and percentage of subjects whose serum urate levels were <6.0 mg/dL,incidence of subjects requiring treatment for a gout flare,change in tophus size based on MRI measurements
Not Provided
Not Provided
 
Long-Term Safety of Febuxostat in Subjects With Gout.
Phase II, Open-Label Study, to Assess the Long-Term Safety of Oral TMX-67 in Subjects With Gout

The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.

Uric acid is the end product of purine degradation in humans. Hyperuricemia, a urate concentration in serum exceeding the limit of urate solubility (approximately 7.0 milligrams per deciliter [mg/dL]), is a common biochemical abnormality. Aberrations in any of the multiple mechanisms involved in the production and/or excretion of uric acid may increase serum urate concentrations, with persistent hyperuricemia as a marker for extracellular fluid monosodium urate supersaturation. As such, hyperuricemia is a necessary (but often not sufficient) risk factor for monosodium urate crystal deposition in tissues and is the fundamental pathophysiological process underlying the clinical manifestations of gout, which is a chronic disease characterized by urate crystal formation and deposition in joints and bones. Gout may progress from episodic attacks of acute inflammatory arthritis to a disabling chronic disorder characterized by deforming arthropathy; destructive deposits of urate crystals (tophi) in bones, joints, and other organs; structural and functional renal impairment due to interstitial urate crystal deposition; and urinary tract stones composed entirely or in part of uric acid crystals. Management of gout requires chronic treatment aimed at lowering serum urate into a subsaturating range (usually <6.0 mg/dL) in which crystal formation and deposition are prevented or reversed.

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.

Subjects who want to participate in this study will have successfully completed study TMX-00-004 (NCT00174967).

All participants will initially receive an 80 mg dose. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gout
  • Drug: Febuxostat
    Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level.
    Other Names:
    • TMX-67
    • Tei-6720
    • Uloric
  • Drug: Febuxostat
    Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level.
    Other Names:
    • TMX-67
    • Tei-6720
    • Uloric
  • Drug: Febuxostat
    Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.
    Other Names:
    • TMX-67
    • Tei-6720
    • Uloric
  • Experimental: 1
    Intervention: Drug: Febuxostat
  • Experimental: 2
    Intervention: Drug: Febuxostat
  • Experimental: 3
    Intervention: Drug: Febuxostat

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hyperuricemia (serum uric acid ≥8.0 mg/dL upon entering parent study TMX-00-004).
  • Must meet American College of Rheumatology criteria for gout.
  • Must have adequate renal function (serum creatinine <1.5 mg/dL).
  • Must have completed four weeks of double-blind dosing in Study TMX-00-004.
  • Must not have experienced any serious study drug-related Adverse Events in Study TMX 00-004.
  • 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.

Exclusion Criteria:

  • 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 kg/m2
  • Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00174941
TMX-01-005, U1111-1114-2039
No
Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
Takeda
Not Provided
Study Chair: Medical Director Takeda
Takeda
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP