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Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects. (APEX)

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ClinicalTrials.gov Identifier: NCT00174915
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : July 16, 2009
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 15, 2005
Results First Submitted Date March 12, 2009
Results First Posted Date July 16, 2009
Last Update Posted Date February 2, 2012
Study Start Date  ICMJE February 2003
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). [ Time Frame: Last 3 visits (any last 3 visits up to week 28) ]
Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
The proportion of subjects whose last three serum urate levels are < 6.0 mg/dL.
Change History Complete list of historical versions of study NCT00174915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
  • Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28 [ Time Frame: Week 28 ]
    Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized.
  • Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit [ Time Frame: Final Visit (up to 28 weeks). ]
    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 and may have differed by subject.
  • Percent Change From Baseline in Serum Urate Levels at Week 28. [ Time Frame: Baseline and Week 28 ]
    Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(Week 28 - baseline levels)/baseline]*100 and summarized.
  • Percent Change From Baseline in Serum Urate Levels at Final Visit [ Time Frame: Baseline and Final Visit (up to 28 weeks) ]
    The percent change in serum urate from baseline to the Final visit was summarized. The percent change in serum urate was calculated as [(Final visit - baseline levels)/baseline]*100. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject.
  • Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. [ Time Frame: Baseline and Week 28 ]
    The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero.
  • Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. [ Time Frame: Baseline and Final Visit (up to 28 weeks) ]
    Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject.
  • Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit. [ Time Frame: Baseline and Week 28 ]
    Change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were not palpable at the Week 28 visit, the total count was assumed to be 0.
  • Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit [ Time Frame: Final Visit (up to 28 weeks) ]
    Change in number of tophi/subject was calculated for the subset of subjects with palpable tophi at the Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject.
  • Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period. [ Time Frame: Weeks 8 through 28 ]
    Percentage of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • 1) The proportion of subjects whose serum rate levels are <6.0 mg/dL;
  • 2) The percent reduction in serum urate levels;
  • 3) The percent reduction in primary tophus size, as determined by physical measurement in the subset of subjects with palpable tophi at the Screening Visit;
  • 4) The reduction in the total number of tophi in the subset of subjects with palpable tophi at the Screening Visit; and
  • 5) The proportion of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the Double-Blind Treatment Period.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
Official Title  ICMJE A Phase 3, Randomized, Multicenter, Allopurinol and Placebo-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout.
Brief Summary The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.
Detailed Description

A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for those with normal renal function and 100 mg for those with impaired renal function) and placebo administered once daily in subjects with gout.

Subjects will receive treatment for 28 weeks.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gout
Intervention  ICMJE
  • Drug: Febuxostat
    Febuxostat 80 mg, orally, once daily for up to 28 weeks.
    Other Names:
    • TMX-67
    • Tei-6720
    • Uloric
  • Drug: Febuxostat
    Febuxostat 120 mg, orally, once daily for up to 28 weeks.
    Other Names:
    • TMX-67
    • Tei-6720
    • Uloric
  • Drug: Febuxostat
    Febuxostat 240 mg, orally, once daily for up to 28 weeks.
    Other Names:
    • TMX-67
    • Tei-6720
    • Uloric
  • Drug: Allopurinol
    Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
  • Drug: Placebo
    Placebo, orally, once daily for up to 28 weeks.
Study Arms
  • Experimental: Febuxostat 80 mg QD
    Intervention: Drug: Febuxostat
  • Experimental: Febuxostat 120 mg QD
    Intervention: Drug: Febuxostat
  • Experimental: Febuxostat 240 mg QD
    Intervention: Drug: Febuxostat
  • Active Comparator: Allopurinol QD
    Intervention: Drug: Allopurinol
  • Placebo Comparator: Placebo QD
    Intervention: Drug: Placebo
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)
1072
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
1000
Actual Study Completion Date April 2004
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association Criteria
  • Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 milliliters per minute (mL/min) by Cockroft and Gault formula.

Exclusion Criteria:

  • History of xanthinuria
  • Intolerance to allopurinol
  • Presence of renal calculi,
  • Alcohol intake of ≥ 14 drinks/week
  • Clinically significant medical condition
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers 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 NCT00174915
Other Study ID Numbers  ICMJE C02-009
U1111-1113-9740 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Takeda
PRS Account Takeda
Verification Date January 2012

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