2024-515547-34-00暂停3 期
Non-inferiority study of a new therapeutic strategy for gout: immediate prescription of a hypouricemia treatment, febuxostat, compared to its deferred administration. FEFACRIGOU
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 128
- 试验地点
- 6
- 主要终点
- 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
研究概览
简要总结
The primary objective is to compare the number of days with gout at 42 days +/- 3 days (S6) in patients with early administration of febuxostat from the acute attack versus patients with delayed administration of febuxostat by 6 weeks after the acute attack.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patients with an attack of gout, diagnosed immediately or less than 5 days old. Gout is defined according to American-European criteria (Appendix 3).
- •Attack of gout affecting one (or more) peripheral joint (s) whatever (s) it (s): • Either a first crisis, • Either a new attack of a gout not treated with a hypo-uricemic or for which the hypo-uricemic treatment has not been taken for at least 6 months.
- •Uricemia ≥ 420 μmol / l, including under a diuretic (dosage carried out within 10 days before inclusion),
- •Age ≥ 18 years old
- •Patient with a creatinine clearance ≥ 30 ml / min (dosage carried out within 10 days before inclusion)
- •Patient having read and understood the information letter and signed the consent form
- •Affiliation to a social security scheme
- •Woman of childbearing potential with effective contraception according to WHO definition (estrogen-progestins or intrauterine device or tubal ligation for more than 1 month and to be continued for at least 5 weeks after the last dose of the drug. ) and a negative urine pregnancy test on inclusion and throughout the duration of the study.
- •Postmenopausal woman: amenorrhea not medically induced for at least 12 months before the inclusion visit.
排除标准
- •Patients under the age of 18
- •Person with rare hereditary disorders of galactose intolerance, lactase deficiency or glucose / galactose malabsorption
- •Poor understanding of the project due to neurological disease or lack of French practice
- •Pregnant woman or likely to be in the absence of effective contraception (Women of childbearing age should have a negative urine pregnancy test)
- •Breastfeeding woman
- •Any history of pre-existing major cardiovascular disease (myocardial infarction, stroke, unstable angina, etc.), metabolic, endocrine, psychiatric or cancerous in uncontrolled development
- •Person deprived of liberty by an administrative or judicial decision
- •Person placed under judicial protection, guardianship or curatorship
- •Participating patient who participated in the month preceding inclusion in another interventional drug trial
- •Stop taking a hypouricemic agent for less than 6 months
- •Known contraindication to ADENURIC 80 mg film-coated tablet: hypersensitivity to the active substance (febuxostat) or to one of the excipients
- •Renal failure defined by creatinine clearance <30 ml / min
- •Hepatic disease defined by an increase to more than 2 times the normal of transaminases, alkaline phosphatases, to more than 3 times the normal of gamma-GT
- •Non-weaned alcoholism
- •Crisis more than 5 days old
- •Patient who has received an organ or marrow transplant
- •Person on Naproxen, mercaptopurine, azathioprine, Glycuronidation inhibitors and inducers, theophylline, macrolides, HMG Co-A reductase inhibitors and / or diuretic in combination with an ACE inhibitor or ARAII
结局指标
主要结局
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
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
次要结局
- 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
研究者
MALLET David
Scientific
Centre Hospitalier Universitaire Rouen
研究点 (6)
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