Table 2 Inclusion-exclusion criteria

Inclusion

• Ambulatory, 40–75 years of age, with a BMI of 18 to 30 kg/m²

• Females of childbearing age must agree to use a medically approved form of birth control and have a negative urine pregnancy test result throughout the study

• Female subjects of limited to no childbearing potential must be amenorrheic for at least 1 year or have had a hysterectomy, a bilateral oophorectomy, or both

• Unilateral or bilateral OA of the knee for greater than 3 months plus a Kellgren and Lawrence radiographic grade of 2 or 3

• VAS score during knee movement between 40–70 mm after 7 day withdrawal of excluded medications

• LFI score between 6–10 points after 7 day withdrawal of excluded medications

• Clinical laboratory results that are within normal range or considered not clinically significant by the Principal Investigator

• Be willing to participate in all scheduled visits, tests, and other trial procedures according to the clinical protocol

• Be willing to refrain from taking ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription) during the entire trial other than acetaminophen (paracetamol) as rescue medication

• Provide a signed and dated informed consent indicating that the subject has been informed of all pertinent aspects and possible risks associated with participation in the trial

Exclusion

• History of hypersensitivity to the rescue medication or any of the products used in the study

• History of hypersensitivity to eggs, chicken or fowl, or shellfish

• History of inflammatory arthropathy, severe RA, OA (VAS score greater than 70), or Systemic Lupus Erythematosus

• Hyperuricemia (>440 μmol/L), past history of gout, or both

• Anticipation of surgery within the next 4 months

• Recent injury in the target knee (past 4 months)

• History of use for corticosteroid, indomethacin, glucosamine & chondroitin within 3 months of Visit 2; intra-articular treatments, including injections of corticosteroid or hyaluronic acid; consumption of Omega 3 fatty acids dietary supplements within 6 months preceding the treatment period (a 2-week washout period is allowed for subjects taking omega 3 fatty acid supplements)

• History of congestive heart failure

• Anticipated problems with product consumption

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies within the last 5 years

• High alcohol intake (>2 standard drinks per day) or use of recreational drugs (e.g., cocaine, methamphetamine, marijuana, etc.)

• Females who are pregnant or lactating or planning to become pregnant

• History of any mental illness that might impair the ability of subjects to provide a written informed consent

• Consumed acetaminophen (paracetamol), ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription), or any natural health product, (excluding vitamins) within 7 days of first visit

• Participation in any clinical trials within 30 days prior to first visit