Dose-Response, Safety and Efficacy Study of Oral Febuxostat in Subjects With Gout - Tabular View

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Dose-Response, Safety and Efficacy Study of Oral Febuxostat in Subjects With Gout

This study has been completed.

Study NCT00174967. 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 ^†

Dose-Response, Safety and Efficacy Study of Oral Febuxostat in Subjects With Gout

Official Title ^†

Phase II, Dose-Response, Safety and Efficacy Study of Oral TMX-67 in Subjects With Gout.

Brief Summary

A Phase 2, dose response study of 40 mg, 80 mg and 120 mg/day of febuxostat or placebo for 4 weeks.

Detailed Description

This is a phase two, randomized, double-blind, placebo controlled, multi-center dose response trial designed to determine the oral dose(s) of febuxostat which safely and effectively reduce serum urate levels.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL after treatment with study drug. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Percent reduction in serum urate levels from baseline to the end of the treatment period. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Condition ^†

Gout

Intervention ^†

Drug: Placebo
Drug: Febuxostat

MEDLINE PMIDs

15751090, 16911575

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

153

Start Date ^†

January 2001

Completion Date

July 2001

Eligibility Criteria ^†

Inclusion Criteria:

Hyperuricemia (serum uric acid ≥ 8.0 mg/dl),
Must meet ARA criteria for gout
Must have adequate renal function (serum creatinine < 1.5 mg/dL)

Exclusion Criteria:

History of xanthinuria
Alcohol consumption > 14/week,
History of significant concomitant illness
Active liver disease.

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00174967

Organization ID

TMX-00-004

Secondary IDs ^††

Study Sponsor ^†

Takeda Global Research & Development Center, Inc.

Collaborators ^††

Investigators ^†

Study Chair:

Medical Director

Takeda Global Research & Development Center, 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.