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

Study acronym: FEFACRIGOU
StatusRecruiting
PhasePhase 3
Started2023-08-02
View on ClinicalTrials.gov ↗

Amendment history

2026-06-04
minor
2 amendments v2-v3
2 re-verifications since 2026-01-20, no change to tracked fields
2025-09-24
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-08-01→2027-01-01
Completion date2025-08-01→2027-01-01
Start dateestimated 2022-01-01→confirmed 2023-08-02
Study sites0→6
2021-10-27
minor
Original filing
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.
Trial Details
NCT Number NCT05109936
Lead Sponsor University Hospital, Rouen
Conditions Gout
Enrollment 128 participants
Start Date 2023-08-02
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-08