Phase 3 Gout Trial, Recruiting NCT05658575 Sponsor: Olatec Therapeutics, Inc. Condition: Gout
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Phase 3 Gout Trial, Recruiting

NCT05658575
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older (male or female)
  • You have been diagnosed with gout, confirmed either by a lab test of fluid from the affected joint, by imaging that shows urate (crystal) deposits in the joint, or by a documented history of gout in that joint or at least 2 gout flares in the past 18 months
  • You are currently having a gout flare in the affected joint that started within the last 96 hours (4 days) before your first visit
  • You are willing and able to give written consent and follow all trial requirements

Who may not be able to join:

  • You have visible or feelable lumps under the skin caused by gout (called tophi)
  • You are having a gout flare in 4 or more joints at the same time
  • You have rheumatoid arthritis or another active inflammatory joint condition
  • There is a sign or suspicion of a joint infection
  • You have significant pain from a condition other than gout that could make it hard to accurately rate the pain in the affected joint
  • You have been diagnosed with chronic kidney disease or have a known history of kidney problems
  • You tested positive for COVID-19 within the 4 weeks before your first visit (if tested)
  • You currently have cancer or recently had cancer that required systemic treatment (such as chemotherapy)
  • You have a known allergy or sensitivity to OLT1177® or similar medications (confirm with trial site)
  • You have a known allergy or sensitivity to paracetamol/acetaminophen (e.g., Tylenol/Panadol)
  • You have taken paracetamol/acetaminophen within 4 hours, or other pain medications within 12 hours, before your first visit
  • You are taking or plan to take any other medications that are not allowed during the trial, as outlined in the study rules (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +1 833-652-8321

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Olatec Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
6 January 2023
Est. completion
31 December 2026

Where this trial is recruiting

🇫🇷 France 🇮🇱 Israel 🇳🇱 Netherlands 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

To evaluate the efficacy of dapansutrile as an acute gout flare treatment compared to placebo in reducing joint pain at 72 hours post initial loading dose of IMP

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov