Trials / Completed
CompletedNCT05586958
Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
A Randomized, Multi-regional, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study to Assess the Safety and Efficacy of 6 Months Treatment With Tigulixostat in Gout Patients With Hyperuricemia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 354 (actual)
- Sponsor
- LG Chem · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tigulixostat | Xanthine Oxidase Inhibitor |
| DRUG | Placebo | Matching placebo |
Timeline
- Start date
- 2022-10-25
- Primary completion
- 2024-11-04
- Completion
- 2024-12-16
- First posted
- 2022-10-19
- Last updated
- 2025-10-29
Locations
52 sites across 4 countries: United States, Georgia, Philippines, Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05586958. Inclusion in this directory is not an endorsement.