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

Delivra, Inc.2 sites in 1 country160 target enrollmentJanuary 2015

ConditionsOsteoarthritis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Delivra, Inc.
Enrollment: 160
Locations: 2
Primary Endpoint: Change in mean daily pain diary score from baseline
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

December 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Delivra, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Osteoarthritis of the knee according to American College of Rheumatology criteria: Knee pain with 3:
•age \>50 years
•stiffness less than 30 min
•crepitus,
•bony tenderness,
•bony enlargement,
•no palpable warmth
•Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI).
•All concurrent medications taken for any reason stable for 14 days
•Ability to follow protocol with reference to cognitive and situational factors (eg. stable housing, ability to attend visits)

Exclusion Criteria

•Currently taking opioids, NSAIDs, warfarin, other anticoagulants, other topical agents for treatment of pain or inflammation
•Allergy to tea tree oil, latex, avocado, soy
•Active conditions such as exzema or psoriasis
•Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (eg. cancer, immunosuppressed)
•Individuals with a history or current disease which may affect the outcome of the trial (ie. Inflammatory, infections joint disease).
•Allergy to plants of the Asteraceae/Compositae/Daisy family.
•Pregnant and breastfeeding women.
•Allergy or other contraindication for acetaminophen use.
•Exercise or transcutaneous electrical nerve stimulation should be excluded prior to and during the trial.

Outcomes

Primary Outcomes

Change in mean daily pain diary score from baseline

Time Frame: three weeks

The primary outcome measure will consist of change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final 3 days of the third treatment week. Therefore, the primary analysis is a between group comparison (placebo versus test product) over 3 weeks.