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Inclusion/exclusion criteria |
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| Criteria |
Details |
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| 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 |
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| Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result. |
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| Unilateral or bilateral osteoarthritis of the knee for more than 3 months |
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| Visual analogue scale score during the most painful knee movement between 40 and 70 mm after 7 days of withdrawal of usual medication |
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| Lequesne's Functional Index score greater than 7 points after 7 days of withdrawal of usual medication |
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| Ability to walk |
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| Availability for the duration of the entire study period |
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| Exclusion |
History of underlying inflammatory arthropathy or severe rheumatoid arthritis |
| Hyperuricaemia (>440 μmol/l) and/or past history of gout |
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| Recent injury in the area affected by osteoarthritis of the knee (past 4 months) and expectation of surgery in the next 4 months |
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| Intra-articular corticosteroid injections within the preceding 3 months |
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| 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 |
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| Major abnormal findings on complete blood count, history of coagulopathies, haematological or neurological disorders |
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| High alcohol intake (>2 standard drinks per day) |
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| Pregnant, breastfeeding, or planning to become pregnant during the study |
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| Use of concomitant prohibited medication other than ibuprofen |
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| Obesity (body mass index > 30 kg/m2) |
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Sengupta et al. Arthritis Research & Therapy 2008 10:R85 doi:10.1186/ar2461 |
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