Clinical trial NCT03142178: 3VM for Treatment of Chronic Osteoarthritis Knee Pain
Official title: A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety and Efficacy of 3VM1001 Cream for the Treatment of Chronic Pain Caused by Osteoarthritis of the Knee: A Dose Ranging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Arthritis, Degenerative
Keywords: osteoarthritis
pain
knee
Lead sponsor: CDA Research Group, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-05
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, placebo controlled, randomized
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

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

Primary outcomes:
measure: Time averaged change from baseline in a standard 100 mm Visual Analog Scale (VAS).
timeFrame: 7 days
Secondary outcomes:
measure: Adverse events, Serious adverse events, and study discontinuation
timeFrame: 8 days
measure: Patient global impression of change scale (PGIC) from baseline to end of study period.
timeFrame: 8 days
measure: Change in the global rating of disease for 3VM1001 Cream and placebo from baseline to the end of study.
timeFrame: 8 days
measure: Patient Global Impression of change from baseline in Osteoarthritis (OA) pain..
timeFrame: From screening Day 0 to the end of study (8 days)
measure: Change in Patient Global Assessment of Treatment Satisfaction from baseline to end of study.
timeFrame: 8 days
measure: Use of rescue medication
timeFrame: 8 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Optimed Research, LTD
state: Ohio
Study officials:
References: