Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects. - Tabular View

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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.

This Tabular View shows the required WHO registration data elements as marked by ^†

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

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.