3VM for Treatment of Chronic Osteoarthritis Knee Pain

CDA Research Group

Status and phase: Completed; Phase 2; Phase 1

Conditions: Arthritis, Degenerative

Treatments: Drug: Experimental: 3VM1001 active 2g Cream 3 times daily; Drug: Experimental: 3VM1001 active 3g Cream 3 times daily; Drug: Placebo: 3VM1001 vehicle 3g Cream 3 times daily; Drug: Experimental: 3VM1001 active 3g Cream 4 times daily; Drug: Placebo: 3VM1001 vehicle 2g Cream 3 times daily; Drug: Placebo: 3VM1001 vehicle 3g Cream 4 times daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT03142178

3VM1216

Details and patient eligibility

About

A double-blind, placebo-controlled, randomized dose ranging study for the use of 3VM1001 Cream, 2g three times daily, 3g three times daily, or 3g four times daily for treatment of chronic pain associated with osteoarthritis of the knee compared to inactive placebo.

Full description

The study is a double-blind, placebo-controlled, dose ranging study for the use of 3VM1001 Cream, 2g three times daily, 3g three times daily, or 3g four times daily for the treatment of chronic pain associated with osteoarthritis of the knee compared to the inactive vehicle as a placebo.

A maximum of 120 subjects will be enrolled. Subjects will self-treat for 7 (+2) days, applied in the morning and at bed time.

The active pharmaceutical ingredient is copper. The proposed doses in the study are less than 2% of the upper limit of the RDA (0.9 mg/day, upper limit 10mg/day).

Rescue medication is acetaminophen, up to ~2g daily (Up to six Tylenol Regular Strength tablets).

Enrollment: 150 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 6 patient groups, including a placebo group

Experimental 3VM1001 2g X 3 daily

Experimental group

Description:

3VM1001 active cream administered 2g cream three times daily for seven days

Treatment:

Drug: Experimental: 3VM1001 active 2g Cream 3 times daily

Placebo; 3VM1001 vehicle 2g X 3 daily

Placebo Comparator group

Description:

3VM1001 placebo vehicle administered 2g cream three times daily for seven days

Treatment:

Drug: Placebo: 3VM1001 vehicle 2g Cream 3 times daily

Experimental 3VM1001 3g X 3 daily

Experimental group

Description:

3VM1001 active cream administered 3g cream three times daily for seven days

Treatment:

Drug: Experimental: 3VM1001 active 3g Cream 3 times daily

Placebo; 3VM1001 vehicle 3g X3 daily

Placebo Comparator group

Description:

3VM1001 placebo vehicle administered 3g cream three times daily for seven day

Treatment:

Drug: Placebo: 3VM1001 vehicle 3g Cream 3 times daily

Experimental 3VM1001 3g x 4 daily

Experimental group

Description:

3VM1001 active cream administered 3g cream four times daily for seven days

Treatment:

Drug: Experimental: 3VM1001 active 3g Cream 4 times daily

Placebo; 3VM1001 vehicle 3g X 4 daily

Placebo Comparator group

Description:

3VM1001 placebo vehicle administered 3g cream four times daily for seven days

Treatment:

Drug: Placebo: 3VM1001 vehicle 3g Cream 4 times daily