NCT03142178

3VM for Treatment of Chronic Osteoarthritis Knee Pain

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: CDA Research Group, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Arthritis, Degenerative

Interventions

Type	Name	Description
DRUG	Experimental: 3VM1001 active 2g Cream 3 times daily	3VM1001 2g Cream with active ingredient administered 3 times daily
DRUG	Experimental: 3VM1001 active 3g Cream 3 times daily	3VM1001 3g Cream with active ingredient administered 3 times daily
DRUG	Experimental: 3VM1001 active 3g Cream 4 times daily	3VM1001 3g Cream with active ingredient administered 4 times daily
DRUG	Placebo: 3VM1001 vehicle 2g Cream 3 times daily	3VM1001 placebo 2g vehicle Cream administered 3 times daily
DRUG	Placebo: 3VM1001 vehicle 3g Cream 3 times daily	3VM1001 placebo 3g vehicle Cream administered 3 times daily
DRUG	Placebo: 3VM1001 vehicle 3g Cream 4 times daily	3VM1001 placebo 3g vehicle Cream administered 4 times daily

Timeline

• Start date: 2017-04-30
• Primary completion: 2018-01-30
• Completion: 2018-06-01
• First posted: 2017-05-05
• Last updated: 2018-07-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study