Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Osteoarthritis of the knee according to American College of Rheumatology clinical radiological criteria;
OA of knee ≥ 6 months prior to screening;
age 40 years or older;
subjects of childbearing potential and their partners must use effective contraception;
women of childbearing age must have a negative pregnancy test or screening or be using an acceptable form of birth control;
moderate to severe chronic OA pain defined as POM score between 40 mm and 90 mm;
baseline WOMAC pain subscale score ≥ 9;
no change in physical activity and/or therapy for the past 3 months;- all concurrent medications taken for any reason stable for 14 days;
ability to follow protocol with reference to cognitive and situational factors (eg. stable housing, ability to attend visits;
ability to read and write English;
ability to apply cream without assistance;
able to provide written informed consent.

Exclusion Criteria:

Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (e.g. cancer, immunosuppressed) or evidence of alcohol or substance abuse;
Wilson's disease or other disorder of copper metabolism
BMI >35
Known hypersensitivity or allergy to any component of the product, or to acetaminophen
Pregnant and breastfeeding women
Transcutaneous electrical nerve stimulation and use of crutches, walkers, or wheel chairs should be excluded prior to and during treatment
Active conditions over the area to be treated such as eczema or psoriasis, compromised integrity of the intact, superficial skin layer over the area to be treated.
Pain in any joint other than the index joint that could interfere with the patient's assessment of pain in the index joint
Recent injury (traumatic or sports related) to either knee causing pain and interference with daily activities (e.g. walking)
Recent surgery/procedure to either knee causing pain that could interfere with study assessments of pain, function, and QoL.
Extreme pain in the target knee characterized by POM score of >90 mm
Mild pain in the target knee, characterized by POM score of < 40 mm
Open surgery of the target knee within the last year
Arthroscopic surgery of the target knee within the last 3 months

Use of prohibited concomitant medications/therapies during the 30-day treatment period including:

devices or therapeutic treatments for knee pain or ambulation
analgesics other than acetaminophen
Systemic corticosteroids
other investigational drugs
chemotherapeutic drugs
immunotherapy
topical products applied to the target knee