Comparison of Maximum Blood Concentrations of Colchicine Between Responders and Non-responders to Colchicine Treatment During Gout Flare

P170409J

Gout, secondary to sodium urate crystal deposition, is responsible of recurrent inflammatory painful flares. Efficacy of colchicine which is the first line drug for the treatment and prophylaxis of gout flare varies and only half of treated patients experience good response. This study aims to optimize colchicine prescription for the treatment and prophylaxis of gout flare. Current data suggest that efficiency of colchicine relies on its maximum blood concentration (Cmax). In this study, the investigators hypothesize that responders to colchicine treatment have higher colchicine Cmax than non-responder patients following the recommended dose regimen (1 mg then 0.5 mg 1 hour later). The individual pharmacokinetics (PK) of colchicine remains poorly investigated while the assessment of individual drug metabolisms can be performed. The hypothesis of this study stands that several factors contribute to the variability of colchicine Cmax. The analysis of individual PK profile and a well-characterized metabolism of colchicine will permit a personalized treatment regimen for the treatment and prophylaxis of gout flares.

2019-09-10

2019-10-10

2024-02-28

Terminated

Early phase I

26

Inclusion Criteria: Patients (\> 18 years old) with gout flare defined by following items : * Identification of sodium urate crystals in synovial fluid analysis * Or gout flare diagnosis according to Nijmegen criteria (score \> 8/13) * Man (2 pts) * History of flare (2 pts) * Flare involving first metatarsophalangeal joint (2.5 pts) * Maximum of flare within 24h (0.5pt), * Redness (1 pt), * History of hypertension or cardiovascular diseases (1.5 pts), * Serum urate level \> 360 µmol/l during flare (3.5 pts) * Duration of flare \< 48 h * Monoarticular involvement Exclusion Criteria: * Hypersensitivity to colchicine, fexofenadine, benzodiazepine or the excipients of these drugs * Contra-indication to colchicine : chronic kidney disease stage 4-5, severe hepatic impairment, treatment by macrolide antibiotics * Used of pain-killers other than acetaminophen * Involvement in another clinical trial with drug administration * Illiteracy * Pregnant woman or breastfeeding

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'all participants will perform the pharmacokinetic study and take colchicine 1 mg + 0.5 mg 1 hour later, midazolam 1 mg and fexofenadine 120 mg.\n\nA pharmacokinetic study is an interventional study with only one arm.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'all participants will perform the pharmacokinetic study and take colchicine 1 mg + 0.5 mg 1 hour later, midazolam 1 mg and fexofenadine 120 mg.'}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}

2024-06-03