Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of Dapansutrile and Paracetamol for Patients with Acute Gout Flare

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of an acute gout flare, a condition characterized by sudden and severe pain in the joints, often affecting the big toe. The study will use a medication called dapansutrile, which is taken in the form of a tablet. The purpose of the study is to evaluate how effective dapansutrile is in reducing joint pain compared to a placebo.

Participants in the study will be randomly assigned to receive either dapansutrile or a placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are unbiased. The study will last for a short period, during which participants will take the medication and report on their pain levels at various intervals.

In addition to dapansutrile, the study will also involve the use of paracetamol, a common pain reliever, to help manage symptoms. Participants will be monitored closely to assess any changes in their condition and to ensure their safety throughout the study. The goal is to determine if dapansutrile can effectively reduce the pain associated with an acute gout flare, providing a potential new treatment option for those affected by this painful condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, a clinical diagnosis of gout, and a recent gout flare.

    Written informed consent is required before any study-related procedures begin.

  2. Step 2

    Baseline visit

    The baseline visit occurs within 96 hours of the onset of a gout flare.

    Pain intensity in the affected joint is assessed using a visual scale from 0 to 100.

  3. Step 3

    Initial medication administration

    The study involves taking either dapansutrile or a placebo in tablet form, administered orally.

    The primary goal is to evaluate the reduction in joint pain 72 hours after the initial dose.

  4. Step 4

    Follow-up assessments

    Pain intensity is measured at 12, 24, 36, 48, and 60 hours after the initial dose, and on Day 8 and Day 15.

    Additional assessments include joint tenderness, swelling, and overall health questionnaires.

  5. Step 5

    Completion of study

    The study concludes with a final assessment on Day 15.

    The effectiveness of dapansutrile compared to placebo is determined based on changes in pain intensity and other health measures.

Who can join the trial?

6 criteria

  • Men and women who are **18 years of age or older**.
  • Must have a **clinical diagnosis of gout**. This means the doctor has confirmed gout using specific criteria or tests. This can include finding **monosodium urate (MSU) crystals** in the joint fluid or seeing signs of urate deposits in the joint through imaging tests.
  • Must have a **gout flare** in the target joint that started within the last **96 hours**. This is confirmed if the patient reports joint pain at rest of **50 mm or more** on a scale from 0 to 100, and at least two of the following: the patient reports a flare, a warm joint, or a swollen joint.
  • Must be in an **acceptable overall medical condition** to safely participate in the study, especially concerning heart, kidney, and liver health, as determined by the study doctor.
  • Must be **able and willing to provide written informed consent** before starting any study-related procedures. This means agreeing to participate after understanding the study details.
  • Must be able, in the opinion of the study doctor, to **understand and follow all study requirements**, including rules about using certain medications for pain relief.

Who cannot join the trial?

3 criteria

  • Patients who are not experiencing an acute gout flare cannot participate. An acute gout flare is a sudden and severe attack of pain, redness, and swelling in the joints.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have additional risks or require special protection in research.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Dapansutrile is being studied for its effectiveness in treating acute gout flares. It is designed to help reduce joint pain within 72 hours after the initial dose. This medication is being compared to a placebo to determine its safety and efficacy in managing the symptoms of gout.

What is already known about the treatment

Dapansutrile – This medication is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating acute gout flares. The main therapeutic indication is to reduce joint pain associated with acute gout attacks. Dapansutrile works by inhibiting a specific protein involved in inflammation, which helps decrease swelling and pain in the joints. It is classified as an anti-inflammatory agent.

Investigated diseases

Acute Gout Flare – Acute gout flare is a sudden and intense episode of joint pain, often affecting the big toe, but it can occur in other joints as well. This condition is caused by the accumulation of uric acid crystals in the joint, leading to inflammation and severe pain. The affected joint may become red, swollen, and extremely tender to touch. These flares can occur without warning and may last for several days. Over time, repeated flares can lead to joint damage and decreased mobility. Managing the underlying uric acid levels is crucial to prevent future flares.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-518844-20-00Protocol codeOLT1177-08Estimated enrolment300 patientsSponsorOlatec Therapeutics LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.