A multicentre study of the dose concentration response of febuxostat in patients with chronic gout.

Phase 4

Recruiting

• Conditions: Inflammatory and Immune System - Other inflammatory or immune system disorders; Gout; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12616000959471
• Lead Sponsor: St Vincent's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-21
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients for whom febuxostat is, or has been, clinically indicated for the treatment of chronic gout.

Exclusion Criteria

1) Any patient with a past history of febuxostat hypersensitivity.
2) Patients taking xanthine oxidoreductase substrates such as mercaptopurine/azathioprine or theophylline (no studies to substantiate the combination with febuxostat).*
3) Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
4) Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The PD parameter to be assessed is the change in serum urate concentrations. [Baseline serum urate (not during an acute attack) and change in serum urate post treatment (at least 1 week after the initiation and/or dose change). <br><br>]

Secondary Outcome Measures

Name	Time	Method
The pharmacokinetic parameters to be assessed include; the plasma area under the concentration time curve, apparent clearance, and peak and trough concentrations of febuxostat. The relationship of an individual’s pharmacokinetic parameters with the reduction in serum urate concentrations will be explored and reported as mathematical equations. [Up to 4 blood samples (10 mL each) will be collected at least one week after intervention commencement and/or dose adjustment. ]