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A Study of Dotinurad Versus Allopurinol in Participants With Gout

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary endpoints: details revised at 1 of 1 entry
    • Trial sites expanded: 109 → 115 locations
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 5 of 13 entries
  2. Trial sites expanded: 103 → 109 locationsv18
  3. Trial sites expanded: 100 → 103 locationsv17
  4. Eligibility criteria expanded, about 8 words
    • Secondary endpoints revised (13)
    v16
  5. Trial sites expanded: 95 → 100 locationsv15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites revised (95)v14
  2. Site details revised at 11 of 95 sitesv13
  3. Site details revised at 3 of 95 sitesv12
  4. Site details revised at 1 of 95 sitesv11
  5. Study sites: 91 to 95v10
  6. Study sites: 72 to 91v9
  7. Study sites: 66 to 72v8
  8. Study sites: 44 to 66v7
  9. Study sites: 26 to 44v6
  10. Study sites: 6 to 26v5
  11. Study sites: 1 to 6
    • Primary completion date: Aug 2027 to Nov 29, 2027
    • Study completion date: Sep 2027 to Nov 29, 2027
    • Start date changed from estimate of Aug 2025 to Aug 1, 2025
    v4
  12. Start date: Jul 30, 2025 to Aug 2025v3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 hyperuricemia associated with gout.
Trial Details
NCT Number NCT07089875
Lead Sponsor Crystalys Therapeutics
Conditions
(from sponsor)		 Gout
Related terms Gout, Hyperuricemia
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov