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Table 1 Inclusion/exclusion criteria

From: A double blind, randomized, placebo controlled study of the efficacy and safety of 5-Loxin®for treatment of osteoarthritis of the knee




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


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)