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Optimising allopurinol therapy in the treatment of gout.

Understanding the dose-response relationship of allopurinol in patients with gout.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000743965
Enrollment
37
Registered
2011-07-15
Start date
2008-11-13
Completion date
2010-07-20
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Gout is the most common inflammatory disease in the western hemisphere where its incidence seems to be rising. Allopurinol is a widely used and effective treatment for gout. It is used to lower plasma urate concentrations in the body, which in-turn prevents acute gout attacks. It's use, however, has been shown to be sub-optimal. Patients are not reaching target plasma urate concentrations recommended by treatment guidelines due to low dosing of allopurinol. Thus this project aims to understand the dose-response relationship of allopurinol and optimise the dose for patients, such that patients reach target plasma urate concentrations.

Interventions

Patients who have gout and not yet taking allopurinol will be recruited. They will then start with a low dose of allopurinol taken by oral tablet. This low dose will be 50 mg/day (for low renal function) or 100 mg/day (for normal renal function). Patients will take allopurinol for at least 1-2 weeks, being sufficient time to reach steady state concentrations (depending on renal function). Patients will then have the following measured: plasma and urinary urate and creatinine concentrations using

Patients who have gout and not yet taking allopurinol will be recruited. They will then start with a low dose of allopurinol taken by oral tablet. This low dose will be 50 mg/day (for low renal function) or 100 mg/day (for normal renal function). Patients will take allopurinol for at least 1-2 weeks, being sufficient time to reach steady state concentrations (depending on renal function). Patients will then have the following measured: plasma and urinary urate and creatinine concentrations using standard biochemical analyses and plasma oxypurinol concentrations using a validated method. Based on the efficacy of the dose of allopurinol in lowering plasma urate concentrations and at the discretion of the consultant rheumatologist, the rate of the dose increase and the size of the dose increase will rise. Two weeks after each dose increase, the above mentioned analytes will again be measured. This intervention will continue until the plasma urate concentrations drop to 0.30 mg/L.

Sponsors

Richard Day
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Suffer from clinically diagnosed gout and commencing allopurinol therapy

Exclusion criteria

Poor venous access for venepuncture.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 25, 2026