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RECRUITING
NCT05109936
PHASE3

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

Sponsor: University Hospital, Rouen

View on ClinicalTrials.gov

Summary

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.

Official title: Non-inferiority Study of a New Therapeutic Strategy for Gout: Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration - FEFACRIGOU Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2023-08-02

Completion Date

2027-01-01

Last Updated

2026-01-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Adenuric

Immediate prescription (at randomization) of ADENURIC 80 mg / day (febuxostat), hypo-uricemic treatment, for a period of 2 x 6 weeks

Locations (6)

CHU de Caen

Caen, France

Centre Hospitalier Public du Cotentin

Cherbourg, France

CHG Dieppe

Dieppe, France

CHI Elbeuf, Louvier, Val de Reuil

Elbeuf, France

GH Le Havre

Le Havre, France

CHU de Rouen

Rouen, France