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

This study has been completed.
Study NCT00174915.   Last updated on November 18, 2008.   Information provided by Takeda Global Research & Development Center, Inc.

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Descriptive Information Fields
Brief Title  Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
Official Title  A Phase 3, Randomized, Multicenter, Allopurinol and Placebo-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout.
Brief Summary

A Study comparing febuxostat, allopurinol and placebo 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 Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  The proportion of subjects whose last three serum urate levels are < 6.0 mg/dL. [ Time Frame: Weeks 2,4,8,12,16,20,24,and 28 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  The proportion of subjects whose serum urate levels are <6.0 mg/dL; [ Time Frame: Week 28 and Final Visit ] [ Designated as safety issue: No ]
The percent reduction in serum urate levels; [ Time Frame: Week 28 and Final Visit ] [ Designated as safety issue: No ]
The percent reduction in primary tophus size, as determined by physical measurement in the subset of subjects with palpable tophi at the Screening Visit.; [ Time Frame: Week 28 and Final Visit ] [ Designated as safety issue: No ]
The reduction in the total number of tophi in the subset of subjects with palpable tophi at the Screening Visit; [ Time Frame: Week 28 and Final Visit ] [ Designated as safety issue: No ]
The proportion of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the Double-Blind Treatment Period. [ Time Frame: Weeks 8-28 in 4 week intervals ] [ Designated as safety issue: No ]
Condition  Gout
Intervention  Drug: Febuxostat
Drug: Allopurinol
Drug: Placebo
MEDLINE PMIDs 18975369,   18600509
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  1072
Start Date  February 2003
Completion Date April 2004
Eligibility Criteria 

Inclusion Criteria:

  • Hyperuricemia (sUA ≥8.0mg/dL) and gout by ARA Criteria
  • Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 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
Gender Both
Ages 18 Years to 85 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00174915
Organization ID C02-009
Secondary IDs ††
Study Sponsor  Takeda Global Research & Development Center, Inc.
Collaborators ††
Investigators 
Study Chair:     Medical Director     TAP Pharmaceutical Products Inc.    
Information Provided By Takeda Global Research & Development Center, Inc.
Verification Date November 2008
First Received Date  September 9, 2005
Last Updated Date November 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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