Non-inferiority study of a new therapeutic strategy for gout: immediate prescription of a hypouricemia treatment, febuxostat, compared to its deferred administration. FEFACRIGOU

Conditions

The gout

Brief summary

The primary endpoint was the number of days with gout at 42 days (S6), as assessed by the daily logbook (Appendix 7) given to the patient, enabling him to record daily whether or not he had suffered from gout

Detailed description

Pain measured by the EVA centimetric scale at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days, HAQ questionnaire score (Appendix 6) at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days, SF36 questionnaire score (Appendix 5) at 42 (S6), 84 (S12) and 182 (S26) days and walking perimeter at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days for patient function, Treatment tolerance assessed by the number of adverse events at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days, Number of relapses, with crisis defined by assessed criteria (34) (Appendix 4) at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days, The number of days with gout, assessed using the daily logbook (Appendix 7) given to the patient, which enables him or her to indicate whether or not he or she has suffered from gout on 14 (S2), 84 (S12) and 182 (S26) days

Related papers

No related papers found yet.

Interventions

DRUGFebuxostat Viatris 80 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint was the number of days with gout at 42 days (S6), as assessed by the daily logbook (Appendix 7) given to the patient, enabling him to record daily whether or not he had suffered from gout	—

Secondary

Measure	Time frame
Pain measured by the EVA centimetric scale at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days, HAQ questionnaire score (Appendix 6) at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days, SF36 questionnaire score (Appendix 5) at 42 (S6), 84 (S12) and 182 (S26) days and walking perimeter at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days for patient function, Treatment tolerance assessed by the number of adverse events at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days, Number of relapses, with crisis defined by assessed criteria (34) (Appendix 4) at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days, The number of days with gout, assessed using the daily logbook (Appendix 7) given to the patient, which enables him or her to indicate whether or not he or she has suffered from gout on 14 (S2), 84 (S12) and 182 (S26) days	—

Measure

Time frame

Pain measured by the EVA centimetric scale at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days, HAQ questionnaire score (Appendix 6) at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days, SF36 questionnaire score (Appendix 5) at 42 (S6), 84 (S12) and 182 (S26) days and walking perimeter at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days for patient function, Treatment tolerance assessed by the number of adverse events at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days, Number of relapses, with crisis defined by assessed criteria (34) (Appendix 4) at 14 (S2), 42 (S6), 84 (S12) and 182 (S26) days, The number of days with gout, assessed using the daily logbook (Appendix 7) given to the patient, which enables him or her to indicate whether or not he or she has suffered from gout on 14 (S2), 84 (S12) and 182 (S26) days

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Countries

France

Outcome results

None listed