NCT02332148

Assessment of the Safety and Efficacy of 3VM1001 Cream for Treatment of Chronic Pain Caused by Knee Osteoarthritis.

A Double-blind, Placebo-controlled, Randomized Study to Assess the Safety and Efficacy of 3VM1001 Cream for the Treatment of Chronic Pain Caused by Osteoarthritis of the Knee: A Proof of Concept Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: CDA Research Group, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

3VM1001 is a topical cream that may be useful for the treatment of chronic osteoarthritis of the knee. This proof of concept study is a randomized, placebo-controlled, double-blind study to compare treatment with 3VM1001 cream to an inactive cream placebo. Subjects will self-treat for 30 days.

Detailed description

3VM1001 is a topical cream that may be useful for the treatment of chronic osteoarthritis of the knee. This proof of concept study is a randomized, placebo-controlled, double-blind study to compare treatment with 3VM1001 cream to an inactive cream placebo. Subjects will self-treat for 30 days with investigational drug or placebo. Rescue medication with acetaminophen, up to 2g daily, is permitted. This study is intended to evaluate the safety and efficacy of 3VM1001 topical cream, a copper-containing cream. Subjects will self treat with drug or placebo three times daily for 30 days. All subjects will have a total of three visits to the clinic and will complete a daily diary each day for the 30 days of treatment.

Conditions

• Osteoarthritis of Knee

Interventions

Type	Name	Description
DRUG	3VM1001	3VM1001 topical cream for treatment of osteoarthritis of the knee
DRUG	Placebo for 3VM1001	Topical cream placebo for 3VM1001; cream without 3VM1001

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-10-01
• Completion: 2016-03-01
• First posted: 2015-01-06
• Last updated: 2015-08-21