Effectiveness of metformin for knee osteoarthritis with obesity - a randomised, double-blind, placebo-controlled trial of a potential disease modifying therapy

Flavia Cicuttini0 个研究点目标入组 107 人开始时间: 2021年6月8日最近更新: 2023年11月27日

适应症

试验速览

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•1. Men and women aged over 40 years, with overweight or obesity (body mass index greater than or equal to 25 kg/m2);
•2. Knee pain for at least 6 months with a pain score greater than or equal to 40 mm on a 100 mm visual analogue scale (VAS);
•3. Meet the American College of Rheumatology clinical criteria for knee osteoarthritis.

•1. Severe radiographic knee osteoarthritis (Kellgren-Lawrence grade 4) or severe knee pain (on standing >80 mm on a 100 mm VAS);
•2. Any inflammatory arthritis or significant knee injury;
•3. Known or newly diagnosed diabetes requiring anti-hyperglycemic therapy or previous adverse reaction to metformin;
•4. Index knee surgery (arthroscopy or open surgery) in the past year;
•5. Index knee intra-articular hyaluronic acid injection in the past 6 months or corticosteroid injection in the past 3 months;
•6. Use of any investigational drugs or device within 30 days prior to randomisation;
•7. Index knee planned joint replacement or arthroscopy in the next 6 months;
•8. Other muscular, joint or neurological condition affecting lower limb function;
•9. Acute or chronic renal or liver impairment;
•10. Other medical condition precluding study participation or relocation;
•11. Women who are pregnant, lactating or trying to become pregnant. Use of menopausal hormone therapy or oral contraceptive pill will be permitted so long as the dose has been stable for at least 30 days prior to study entry.

发起方

Flavia Cicuttini