Criteria | Details |
---|---|
Inclusion | Patients must understand risks and benefits of the protocol and be able to give informed consent |
Male and female patients aged 40 to 80 years | |
Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result. | |
Unilateral or bilateral osteoarthritis of the knee for more than 3 months | |
Visual analogue scale score during the most painful knee movement between 40 and 70 mm after 7 days of withdrawal of usual medication | |
Lequesne's Functional Index score greater than 7 points after 7 days of withdrawal of usual medication | |
Ability to walk | |
Availability for the duration of the entire study period | |
Exclusion | History of underlying inflammatory arthropathy or severe rheumatoid arthritis |
Hyperuricaemia (>440 μmol/l) and/or past history of gout | |
Recent injury in the area affected by osteoarthritis of the knee (past 4 months) and expectation of surgery in the next 4 months | |
Intra-articular corticosteroid injections within the preceding 3 months | |
Hypersensitivity to nonsteroidal anti-inflammatory drugs, abnormal liver or kidney function tests, history of peptic ulceration and upper gastrointestinal haemorrhage, congestive heart failure, hypertension, hyperkalaemia | |
Major abnormal findings on complete blood count, history of coagulopathies, haematological or neurological disorders | |
High alcohol intake (>2 standard drinks per day) | |
Pregnant, breastfeeding, or planning to become pregnant during the study | |
Use of concomitant prohibited medication other than ibuprofen | |
Obesity (body mass index > 30 kg/m2) |