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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00174941
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : July 16, 2009
Last Update Posted : January 27, 2011
Sponsor:
Information provided by:
Takeda

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 15, 2005
Results First Submitted Date  ICMJE March 12, 2009
Results First Posted Date  ICMJE July 16, 2009
Last Update Posted Date January 27, 2011
Study Start Date  ICMJE March 2001
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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). ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Number of subjects decreasing to or maintaining a serum uric acid of <6.0mg/dL at the final visit.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
  • Percent Change in Serum Urate Levels From Baseline 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.
  • Percent Change in Serum Urate Levels From Baseline at Month 12 Visit. [ Time Frame: Baseline and Month 12 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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). ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Safety of Febuxostat in Subjects With Gout.
Official Title  ICMJE Phase II, Open-Label Study, to Assess the Long-Term Safety of Oral TMX-67 in Subjects With Gout
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gout
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Febuxostat
  • Experimental: 2
    Intervention: Drug: Febuxostat
  • Experimental: 3
    Intervention: Drug: Febuxostat
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2007)
116
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
120
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00174941
Other Study ID Numbers  ICMJE TMX-01-005
U1111-1114-2039 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Medical Director Takeda
PRS Account Takeda
Verification Date January 2011

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