Clinical trial: 3VM for Treatment of Chronic Osteoarthritis Knee Pain (NCT03142178)

Eligibility criteria:
Inclusion Criteria:

          -  Osteoarthritis of the knee according to American College of Rheumatology clinical
             radiological criteria. A knee radiograph will be ordered and reviewed.

          -  OA of the knee >/= 6 months prior to screening. Subjects with OA of both knees will
             treat the worst knee.

          -  Age 40 years or older

          -  Males or females of non-childbearing potential (12 or more months of spontaneous
             amenorrhea, bilateral oophorectomy at least 6 months prior to randomization,
             hysterectomy with bilateral oophorectomy at least 6 months prior to randomization, or
             for females over 50 years of age, hysterectomy without bilateral oophorectomy at least
             6 months prior to randomization.; female subjects of childbearing potential must agree
             to use contraception (abstinence, birth control pills, rings or patches, diaphragm an
             spermicide, intrauterine device, condom and vaginal spermicide, surgical
             sterilization, vasectomy, progestin implant or injection); female partners of
             childbearing potential of male subjects must agree to use contraception as defined
             above.

          -  Moderate to severe OA pain defined a 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 such as
             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 study such as cancer, immunosuppressed, or evidence of
             alcohol or substance abuse.

          -  Wilson's disease or other disorder of copper metabolism.

          -  BMI >40

          -  Known hypersensitivity or allergy to any component of the product, or to
             acetaminophen.

          -  Transcutaneous electrical nerve stimulation and use of crutches, walkers or wheel
             chairs should be excluded prior to and during treatment. Use of a cane is permitted.

          -  Active conditions over the area to be treated such a eczema or psoriasis, compromised
             integrity of the intact, superficial skin layer over the area to be treated.

          -  Pain in any joint being studied that could interfere with the subject's assessment of
             pain in the index joint.

          -  Recent (within 12 months) injury (traumatic or sports related) to either knee causing
             pain and interference with daily activities such as walking.

          -  Recent (within 12 months) surgery/procedure (including intra-articular injection) 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 </= 40 mm.

          -  Mild pain in the target knee characterized by POM score of </= 40 mm.

          -  Open surgery of he target knee within the last year.

          -  Significant concomitant disease of the knee to be studied such as fracture or
             osteonecrosis.

          -  Arthroscopic surgery of the target knee within the last 3 months.

          -  Use of prohibited medications/therapies during he 7-9 day treatment period including:

               1. Devices of therapeutics for knee pain or ambulation

               2. Analgesics other than acetaminpohen

               3. Systemic or locally injected corticosteroids

               4. Other investigational drugs

               5. Chemotherapy drugs

               6. Immunotherapy

               7. Topical products applied to he target knee
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? 1