A Study on the Efficacy of Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Leaf Extract in Adults With Osteoarthritis of the Knee.

A Double Blind, Placebo Controlled Parallel Study on the Efficacy of Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Leaf Extract in Adults With Osteoarthritis of the Knee.

The primary objective of the study is to assess the effectiveness of alpha-D Glucosamine Sulfate/Standardized Extract of Ginkgo Biloba Leaf versus a comparator product on osteoarthritis pain as assessed by the between group change in WOMAC™ Osteoarthritis Index Pain Subscale using Visual Analogue Scale (VAS) scores in subjects with osteoarthritis of the knee.

Inclusion Criteria:

• Male or female 45-70 years of age
• Body mass index (BMI) 18.0-39.9 kg/m2
• If female, subject is not of child bearing potential OR female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
• Primary or secondary, unilateral or bilateral osteoarthritis of the knee (American College of Rheumatology Clinical Criteria for Classification) characterized as knee pain with at least 3 of the following:
• Age > 50 years
• Stiffness < 30 minutes
• Crepitus
• Bony Tenderness
• Bony enlargement
• No palpable warmth
• Self reported difficulty performing at least one of the following activities because of knee pain:
• lifting and carrying groceries
• walking one-quarter of a mile
• getting in and out of a chair
• going up and down stairs
• mobility
• self-care activities
• Able to walk unassisted (may use walking stick, crutch, or knee brace)
• Availability for duration of the study period (2 week run-in +12 weeks)
• Subject agrees not to use over-the-counter medications or natural health products intended to treat OA pain during the run-in period and throughout the study (except the rescue medication provided).
• Subject using other therapies for OA, such as exercise, heat/cold therapy, joint protection and physiotherapy/occupational therapy agrees to continue these therapies as normal avoiding changes in frequency or intensity and to record therapies in the study diary
• Subject agrees not to start any new therapies for OA during the course of the study
• Agrees to maintain current exercise and dietary habits for the duration of the study
• Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
• Physical examination findings show severe articular inflammation
• Subject has a diagnosis of rheumatoid arthritis, fibromyalgia, spinal disorders or other musculoskeletal disease
• Subject has been recommended for knee surgery
• WOMAC Pain Scale Score <4 for total pain (average of question #1 to question #5) at screening and baseline
• Subject has kidney or liver disease, blood disorders, active cancer and/or HIV infection
• Subjects with significant medical history or current metabolic disorders, thyroid disease, immune disorders and/or cardiovascular disease will be reviewed by the Qualified Investigator (QI). Subjects deemed by the QI to be at possible risk will not be permitted in this study.
• Subjects with a Type I or II diabetes
• Subjects with a history of seizures who are currently on medication to control seizures
• Subjects with hypertension will be reviewed by the Qualified Investigator (QI). If the subject is considered to be at risk they will not be permitted in this study
• Subjects with a history of reoccurring palpitations or dizziness
• Use of illicit drugs or history of drug or alcohol abuse with the past 2 years (currently having more than 2 standard alcoholic drinks per day)
• Planned surgery during the course of the trial
• Use of intra-articular, oral or parenteral corticosteroids, or other injectable prescription medication (e.g., Synvisc) within 2 months prior to randomization and during the trial
• Subjects taking prescription medication that affect blood coagulation (e.g. blood thinners, clotting factor replacements, acetylsalicylic acid)
• Subjects regularly taking over-the-counter medication (e.g. acetylsalicylic acid, ibuprofen) or natural health products (i.e. fish oils, vitamin E) that affect blood coagulation within 2 weeks of randomization
• Requires the use of prescription drugs to control pain (other than provided rescue medication)
• Use of oral or topical prescription or over the counter medications or natural health products for pain relief during the run-in period and during the trial (other than provided rescue medication, rescue medication should not be used within 72 hours prior to baseline and subsequent visits)
• Use of vitamins and minerals or natural health products/dietary supplements indicated for arthritis such as glucosamine and chondroitin sulfate within 2 weeks prior to the run-in period and during the trial
• Clinically significant abnormal laboratory results at screening (i.e. ≥ 2 times the ULN)
• Allergy or sensitivity to test product ingredients, including shellfish
• Allergy or sensitivity to acetaminophen, the rescue medication
• Individuals who are cognitively impaired and/or who are unable to give informed consent
• Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject