Osteoarthritis Clinical Trial
Official title:
Randomized, Double Blind, Placebo Controlled Trial With Open Label Extension Of Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee
The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy
of a topical cream compared to a placebo cream. The study population will be those with mild
to moderate osteoarthritis of the knee.
The trial will also provide information about potential side effects and verify the safety of
this composition. Blood levels will be done to assess inflammation and to determine whether
any systemic absorption has occurred.
Hypothesis/Purpose
- Pain scores after active treatment will be significantly reduced in comparison to
placebo.
- There will be an improvement in stiffness and physical function as measured by the WOMAC
using the active cream as compared to placebo.
- There will be a decrease in the level of inflammation assessed at baseline, end of week
3 and end of week 6.
- The blood concentration of the active ingredient in the topical cream will not exceed
the maximum daily dose that will be consumed by participants.
n/a
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