A study comparing the safety and effectiveness of two medicines for Gout

A single centre double blind randomized controlled trial comparing efficacy, cardiorenal and hepatic safety of Topiroxostat vs Febuxostat in patients with gout

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112710

Enrollment

Registered

2026-06-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: M109- Gout, unspecified

Interventions

Intervention1: TOPIROXOSTAT: 40 milligram twice a day Control Intervention1: FEBUXOSTAT: 40 milligram twice a day

Eligibility

Inclusion criteria

Inclusion criteria: Subjects with Serum Uric Acid greater than 7.2 milligram per deciliter (Men) or greater than 6.0 milligram per deciliter (Women). Subjects diagnosed with gout based on American College of Rheumatology Criteria. Subjects providing consent.

Exclusion criteria

Exclusion criteria: Known hypersensitivity to Xanthine Oxidase Inhibitors. History of Hepatic, Renal or Cardiac Impairment. Pregnancy or Lactation. Subjects on other urate lowering therapies.

Design outcomes

Secondary

Measure	Time frame
To determine the proportion of subjects achieving target serum uric acid levels in each group.Timepoint: At Baseline, Week 12;To evaluate cardiac safety via heart rate, blood pressure and ECG Changes.Timepoint: At Baseline, Week 12;To assess renal safety via serum creatinine, estimated glomerular filtration rate and urea levels.Timepoint: At Baseline, Week 12;To evaluate hepatic safety via changes in alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and bilirubin levels.Timepoint: At Baseline, Week 12;To compare the incidence of adverse drug reactions between the groups.Timepoint: Throughout the study	—

Measure

Time frame

To determine the proportion of subjects achieving target serum uric acid levels in each group.Timepoint: At Baseline, Week 12;To evaluate cardiac safety via heart rate, blood pressure and ECG Changes.Timepoint: At Baseline, Week 12;To assess renal safety via serum creatinine, estimated glomerular filtration rate and urea levels.Timepoint: At Baseline, Week 12;To evaluate hepatic safety via changes in alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and bilirubin levels.Timepoint: At Baseline, Week 12;To compare the incidence of adverse drug reactions between the groups.Timepoint: Throughout the study

—

Primary

Measure	Time frame
Serum Uric AcidTimepoint: At Baseline, Week 12	—

Countries

India

Contacts

Public ContactDr Satvik N Pai

Peoples Education Society University Institute of Medical Sciences and Research (PESUIMSR)

satvik.pai@gmail.com9986099798

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026