Comparison of topiroxostat with allopurinol in patients with raised uric acid level with or without gout

Efficacy and safety of topiroxostat compared to allopurinol in hyperuricemic patients with or without gout:A randomized controlled trial - nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080487

Enrollment

138

Registered

2025-02-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: E790- Hyperuricemia without signs of inflammatory arthritis and tophaceous disease

Interventions

Intervention1: Topiroxostat: 40-120 mg (titrated)/day for 16 weeks Control Intervention1: Allopurinol: 100-200 mg (titrated)/day Control Intervention2: Allopurinol: 100-200 mg (titrated)/day for 16 we

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients aged 20 to 64 years with serum urate level in the run-in period of equal to or more than 416.4 micromol/L (or 7.0 mg/dL) in patients with tophi. 2. History of gout attacks or serum urate level equal to or more than 535.4 micromol/L in patients with hyperuricemia. 3. Serum urate level equal to or more than 475.8 micromol/L (or 8.0 mg/dL) in patients who were receiving treatment for or had a diagnosis of urolithiasis, hypertension, hyperlipidemia, or diabetes.

Exclusion criteria

Exclusion criteria: 1. The onset of gouty arthritis within 2 weeks prior to the start of the study drug administration. 2. Primary or secondary hyperuricemia that occurs secondary to specific disorders, including Lesch Nyhan syndrome, hematologic malignancies, or Down s syndrome; HbA1c equal to or more than 8.0% or poorly controlled hyperglycemia. 3. Renal function impairment (eGFR less than or equal to 50 ml/min/1.73 m2). 4. Liver impairment (ALT equal to or more than 100 U/L and/or AST equal to or more than 100 U/L). 5. Severe hypertension (systolic blood pressure equal to or more than 180 mmHg and/or diastolic blood pressure equal to or more than 110 mmHg or poorly controlled condition with hypotensive agent). 6. Use of urate-lowering agents, azathioprine, 6-mercaptoprine, theophylline, the study drug other than topiroxostat, or agents thought to affect the outcomes during the period from 2 weeks prior to the start of the preobservation period until the day of treatment commencement.

Design outcomes

Primary

Measure	Time frame
Change in serum urate level from baseline values upon the final visit.Timepoint: At 16 week	—

Secondary

Measure	Time frame
Proportion of patients achieving target serum urate level [less than or equal to 356.9 micromol/L or 6.0 mg/dL] at different time points.Timepoint: At 2, 6, 16 and 20 weeks.	—

Countries

India

Contacts

Public ContactKumari Pallavi

IGIMS

dr.pallavi3105@gmail.com07783085313

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026