Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Gout: Comparing Immediate vs. Delayed Use of Febuxostat for Patients with Acute Gout Attacks

Verified siteRegistered drugNo placebo
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 a condition known as gout, which is a type of arthritis that causes sudden, severe attacks of pain, swelling, and redness in the joints. The study is investigating a treatment called Febuxostat, which is available in the form of 80 mg film-coated tablets. Febuxostat is a medication that helps to lower uric acid levels in the blood, which can help prevent gout attacks.

The purpose of the study is to compare two different strategies for using Febuxostat in treating gout. One group of participants will start taking Febuxostat immediately after a gout attack, while the other group will begin taking it six weeks after the attack. The study will observe the number of days participants experience gout symptoms over a period of about six weeks. Participants will be asked to keep a daily logbook to record whether they have experienced gout symptoms each day.

Throughout the study, participants will also be monitored for pain levels, overall function, and any side effects they may experience from the treatment. The study will last for several months, with assessments taking place at different intervals to gather comprehensive data on the effectiveness and tolerance of the treatment. This research aims to provide valuable insights into the best timing for starting Febuxostat treatment in managing gout effectively.

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, the patient must have an attack of gout diagnosed immediately or within the last 5 days. The patient must meet specific criteria, including being at least 18 years old and having a certain level of uric acid in the blood.

    The patient must read and understand the information provided and sign a consent form. Women of childbearing potential must use effective contraception and have a negative pregnancy test.

  2. Step 2

    Initial treatment phase

    The patient will begin treatment with Febuxostat Viatris 80 mg film-coated tablets, taken orally. The treatment aims to reduce uric acid levels in the blood.

    The primary objective is to compare the number of days with gout over a period of 42 days, with some patients receiving immediate treatment and others receiving delayed treatment.

  3. Step 3

    Monitoring and assessment

    The patient will maintain a daily logbook to record any days with gout symptoms. This logbook will be used to assess the primary endpoint of the study.

    Pain levels will be measured using a specific scale at 14, 42, 84, and 182 days. Additional assessments will include questionnaires to evaluate the patient's function and treatment tolerance.

  4. Step 4

    Follow-up evaluations

    The patient will undergo follow-up evaluations at specified intervals: 14, 42, 84, and 182 days. These evaluations will include assessments of pain, function, and any adverse events.

    The number of relapses and the number of days with gout will be recorded during these follow-up visits.

  5. Step 5

    Completion of the study

    The study is estimated to end by May 31, 2027. The patient will complete all required assessments and provide final data for analysis.

    The results will contribute to understanding the effectiveness of immediate versus delayed administration of febuxostat in treating gout.

Who can join the trial?

9 criteria

  • Patients must have an attack of gout, which is a type of arthritis, diagnosed immediately or less than 5 days ago.
  • The gout attack should affect one or more peripheral joints, which are joints located in the limbs, such as the hands or feet. It can be a first-time attack or a new attack of gout that hasn't been treated with a medication to lower uric acid levels, or if such treatment hasn't been taken for at least 6 months.
  • The level of uric acid in the blood should be 420 micromoles per liter or higher. This measurement should be done within 10 days before joining the study.
  • Participants must be 18 years old or older.
  • Participants should have a creatinine clearance of 30 milliliters per minute or higher. This is a test to check how well the kidneys are working, and it should be done within 10 days before joining the study.
  • Participants must have read and understood the information letter and signed the consent form, which means they agree to take part in the study.
  • Participants must be affiliated with a social security scheme, which means they have some form of health insurance or coverage.
  • Women who can have children must use effective birth control methods, such as birth control pills, an intrauterine device, or have had a tubal ligation for more than 1 month. They must continue using birth control for at least 5 weeks after the last dose of the study drug. They also need to have a negative urine pregnancy test when joining the study and throughout its duration.
  • Postmenopausal women, who have not had a menstrual period for at least 12 months without medical reasons, can participate.

Who cannot join the trial?

14 criteria

  • Patients who are not experiencing a current gout attack.
  • Patients who have not been diagnosed with gout.
  • Patients who are under 18 years old.
  • Patients who are unable to give consent to participate in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients with severe kidney problems.
  • Patients with severe liver problems.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had an allergic reaction to febuxostat or similar medications.
  • Patients with a history of heart problems, such as heart attack or stroke.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of alcohol or drug abuse.
  • Patients who have had recent surgery or are planning to have surgery during the study period.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to 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.

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.

Not 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

Febuxostat is a medication used to lower uric acid levels in the blood. It is often prescribed to treat gout, a condition characterized by painful joint inflammation due to high uric acid levels. In this clinical trial, febuxostat is being studied to see if starting the treatment immediately during a gout attack is as effective as starting it six weeks after the attack.

What is already known about the treatment

Febuxostat – Febuxostat is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating gout, specifically comparing early versus delayed administration. The main therapeutic indication for febuxostat is the management of gout, a condition characterized by painful joint inflammation due to excess uric acid. At the molecular level, febuxostat works by inhibiting xanthine oxidase, an enzyme responsible for converting purines into uric acid, thereby reducing uric acid levels in the blood. It is classified pharmacologically as a xanthine oxidase inhibitor.

Investigated diseases

Gout – Gout is a type of arthritis characterized by sudden, severe attacks of pain, redness, and swelling in the joints, often affecting the big toe. It occurs when uric acid builds up in the blood, forming sharp crystals in a joint. These attacks can happen suddenly, often waking a person up in the middle of the night with the sensation that the big toe is on fire. The affected joint becomes hot, swollen, and so tender that even the weight of a bedsheet may seem intolerable. Gout attacks can recur over time, potentially leading to chronic gouty arthritis if not managed. The condition is more common in men, but women become increasingly susceptible after menopause.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515547-34-00Protocol code2017/0386/HPEstimated enrolment128 patientsSponsorCentre Hospitalier Universitaire Rouen

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.