Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05109936

Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration

Led by University Hospital, Rouen · Updated on 2026-01-22

128

Participants Needed

6

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Gout, the most common inflammatory rheumatism in France, is a complication of chronic hyperuricemia (\> 360umol / l). The resulting urate crystals are deposited in many tissues, especially the skeletal or kidneys. It appears in the form of spontaneously regressive inflammatory joint attacks in 5 to 7 days but recurrent. Gout turns into a chronic disease if uric acidemia is not reduced, and is responsible for joint destruction. It becomes a vector of renal failure and is associated with cardiovascular morbidity and a reduction in life expectancy. It is cured if a long-term treatment such as febuxostat leading to the normalization of the uric acidemia is administered. However, the frequency of this disease is increasing in industrialized or emerging countries. The causes are numerous, particularly food, but also related to flaws in therapeutic care. Studies show that this treatment is not taken in particular because, after the acute attack, the patient who has become asymptomatic again no longer consults. Currently, in a traditional way and according to European recommendations, it is not prescribed until several weeks after the acute attack in order to avoid early relapses, which would then be more numerous. Nevertheless, even if the hypouricemic agent is prescribed late , the attacks can be repeated and become rare for several months after obtaining a uricemia below 360umol / l; they eventually disappear. Lack of knowledge of this disease largely affects the hazards of disease-modifying treatment, which alone can prevent the progression to chronic inflammatory disease and its cardiovascular and renal impact and on mortality. One of the causes of not taking a hypouricemic agent is its delayed administration. This study is proposed to assess the relevance of early initiation versus delayed administration of such treatment.

CONDITIONS

Official Title

Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a gout attack diagnosed immediately or less than 5 days ago according to American-European criteria
  • Attack affects one or more peripheral joints
  • Either a first gout attack or a new attack without hypouricemic treatment for at least 6 months
  • Uricemia ≥ 420 µmol/l, including under diuretic treatment (tested within 10 days before inclusion)
  • Age 18 years or older
  • Creatinine clearance ≥ 30 ml/min (tested within 10 days before inclusion)
  • Able to read and understand the information letter and sign the consent form
  • Affiliated to a social security scheme
  • Women of childbearing potential must use effective contraception and have a negative urine pregnancy test; postmenopausal women must have amenorrhea for at least 12 months
Not Eligible

You will not qualify if you...

  • Under 18 years old
  • Stopped hypouricemic treatment less than 6 months ago
  • Known allergy to febuxostat or its ingredients
  • Renal failure with creatinine clearance below 30 ml/min
  • Liver disease with elevated liver enzymes beyond specified limits
  • Uncontrolled alcoholism
  • Gout attack more than 5 days old
  • History of organ or bone marrow transplant
  • Use of specific interacting medications (e.g., Naproxen, mercaptopurine, azathioprine, theophylline, macrolides, statins, certain diuretics combined with ACE inhibitors or ARBs)
  • Rare hereditary disorders affecting sugar metabolism
  • Poor understanding due to neurological disease or insufficient French language skills
  • Pregnant or breastfeeding women
  • Major uncontrolled cardiovascular, metabolic, endocrine, psychiatric diseases, or cancer
  • Legal constraints such as imprisonment or guardianship
  • Participation in another interventional drug trial within the last month

AI-Screening

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Trial Site Locations

Total: 6 locations

1

CHU de Caen

Caen, France

Actively Recruiting

2

Centre Hospitalier Public du Cotentin

Cherbourg, France

Actively Recruiting

3

CHG Dieppe

Dieppe, France

Actively Recruiting

4

CHI Elbeuf, Louvier, Val de Reuil

Elbeuf, France

Actively Recruiting

5

GH Le Havre

Le Havre, France

Actively Recruiting

6

CHU de Rouen

Rouen, France

Actively Recruiting

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Research Team

D

David MALLET

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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