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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

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)