A randomised, multi-centre, open-label, active-comparator, pragmatic clinical trial of low-dose colchicine versus naproxen in patients with acute gout. - CONTACT v1.0

Keele University0 个研究点开始时间: 2013年5月8日最近更新: 2017年4月3日

研究概览

暂无简介。

•Adults aged 18 years and over
•Consultation with their GP, primary care out-of-hours service or walk-in-centre that is approved for the trial.
•Current attack of acute gout (first attack or recurrent). The diagnosis of gout will be made on clinical grounds and will not require joint aspiration, blood tests, imaging or clinical criteria.
•Patient has capacity and willingness, in the view of the recruiting clinician, to give consent and complete the trial paperwork, including the symptom diary.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•Known unstable medical conditions (such as ischaemic heart disease, impaired liver function)
•Known stage 4/5 kidney disease (eGFR/creatinine clearance <30ml/min)
•Recent surgery of gastrointestinal bleed
•History of gastric ulcer
•Current anticoagulant use
•Allergy to aspirin/NSAID
•Previous inability to tolerate naproxen or low-dose colchicine
•Other contraindication to either study drug in accordance with the Summary of Product Characteristics (SPC) supplied in the Investigator Site File
•Prescription of naproxen or colchicine in the previous 24 hours
•Pregnant or lactating females
•Potentially vulnerable individuals
•Previous participation in the CONTACT trial during a previous acute attack of gout.
•Involvement in another clinical trial of an investigational medicinal product in the last 90 days or any other research within the last 30 days

发起方