Arthritis, Degenerative Clinical Trial
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
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.
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).
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