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A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

NCT07089888 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-20

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with tophaceous gout.

Conditions

  • Tophaceous Gout

Interventions

DRUG

Allopurinol

Over-encapsulated tablets containing active drug substance administered orally (PO).

DRUG

Dotinurad

Over-encapsulated tablets containing active drug substance administered PO.

Sponsors & Collaborators

  • Crystalys Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-04
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07089888 on ClinicalTrials.gov