Biochemical efficacy and tolerability of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day in gout patients.

Biochemical efficacy and tolerability of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day in gout patients: a randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26727

Enrollment

Registered

2007-02-15

Start date

2006-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

gout, hyperuricemia

Interventions

Arm A: 1dd 300mg allopurinol, when serum urate exceeds 0.30 mmol/L after 8 weeks, dosage is increased to 2dd 300mg

Arm B: 1dd 100mg benzbroamrone, when serum urate exceeds 0.30 mmol/L after 8 weeks, dosage is increased to 1dd 200mg.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis based on crystal evidence or otherwise meeting the ARA criteria; 2. Baseline serum urate measured; 3. Baseline urinary urate excretion measured; 4. Estimated creatinine clearance >50 mL/min.

Exclusion criteria

Exclusion criteria: 1. Contra-indication for study medication: allopurinol or benzbromarone; 2. Poor compliance on allopurinol defined as serum oxipurinol <5 mg/L.

Design outcomes

Primary

Measure	Time frame
Success on study medication: tolerability and attainment of serum urate <0.30 mmol/L.	—

Secondary

Measure	Time frame
1. Relative decrease of serum urate; 2. Adverse drug reactions profile; 3. Pharmacokinetic analysis of serum oxipurinol levels.	—

Contacts

Public ContactM.K. Reinders

Medical Centre Leeuwarden Department of Clinical Pharmacy and Pharmacology Postbox 888

m.reinders@znb.nl0031 58 2866610

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)