NCT02193711

Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Delivra, Inc. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
OTHER	Topical Arthritis Cream

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-11-01
• Completion: 2017-12-01
• First posted: 2014-07-18
• Last updated: 2018-02-01

Locations

2 sites across 1 country: Canada