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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Public Du Cotentin	Cherbourg-En-Cotentin	France
Groupe Hospitalier du Havre – Hôpital Jacques Monod	Montivilliers	France
Centre Hospitalier de Dieppe	Dieppe	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	02.08.2023

Trial locations

Investigated drugs:

Febuxostat

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.

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 ID:

2024-515547-34-00

Protocol code:

2017/0386/HP

NCT ID:

NCT05109936

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?