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A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoints: details revised at 1 of 1 entry
    • Study sites: 94 to 95
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 5 of 16 entries
  2. Minor Trial sites expanded: 89 → 94 locationsv17
  3. Minor Trial sites expanded: 86 → 89 locationsv16
  4. Minor Trial sites expanded: 83 → 86 locationsv15
  5. Minor Trial sites expanded: 78 → 83 locationsv14
Show 12 earlier versionsHide 12 earlier versions
  1. Minor Study sites revised (78)v13
  2. Minor Study sites: 77 to 78v12
  3. Minor Study sites: 68 to 77v11
  4. Minor Study sites: 66 to 68v10
  5. Minor Study sites: 63 to 66v9
  6. Minor Study sites: 57 to 63v8
  7. Minor Study sites: 38 to 57v7
  8. Minor Study sites: 24 to 38v6
  9. Minor Study sites: 6 to 24v5
  10. Minor Study sites: 1 to 6
    • Primary completion date: Sep 2027 to Dec 31, 2027
    • Study completion date: Oct 2027 to Dec 31, 2027
    • Start date changed from estimate of Aug 2025 to Aug 4, 2025
    v4
  11. Minor Start date: Jul 30, 2025 to Aug 2025v3
  12. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 tophaceous gout.
Trial Details
NCT Number NCT07089888
Lead Sponsor Crystalys Therapeutics
Conditions
(from sponsor)
Tophaceous Gout
Related terms Hyperuricemia
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov