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

NCT02193711 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2018-02-01

No results posted yet for this study

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

Interventions

OTHER

Topical Arthritis Cream

Sponsors & Collaborators

  • Delivra, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-11-30
Completion
2017-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02193711 on ClinicalTrials.gov