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3VM for Treatment of Chronic Osteoarthritis Knee Pain

CompletedPhase 1, Phase 2NCT03142178
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

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
Conditions
  • Arthritis, Degenerative
Interventions
  • Drug: Experimental: 3VM1001 active 2g Cream 3 times daily
  • Drug: Experimental: 3VM1001 active 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 3 times daily
  • Drug: Placebo: 3VM1001 vehicle 3g Cream 4 times daily
Sponsor
CDA Research Group, Inc.
Start date
2017-04-30
Primary completion
2018-01-30
Sex
All
Age range
from 40 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 w…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03142178