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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: Topical Arthritis Cream

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • CDHA - Pain Management Unit
  • Ontario
    • Toronto, Ontario, Canada, M2K 1E2
      • Canadian College of Naturopathic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)
• Ability to read and write English
• Willing and able to give informed consent

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical Arthritis Cream; 1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day.	Other: Topical Arthritis Cream; Other Names: LivRelief Pharmax Rebuild
Placebo Comparator: Placebo; 1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day.	Other: Topical Arthritis Cream; Other Names: LivRelief Pharmax Rebuild

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean daily pain diary score from baseline	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.	three weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC	The Western Ontario and McMaster Universities Arthritis Index is a well validated and widely used measure to assess pain, stiffness and physical function in individuals with OA of the knee or hip. It consists of 24 questions divided into 3 scales (pain, stiffness and physical function). This scale has been found to be sensitive to interventions used for osteoarthritis and is noted by IMMPACT as an example of an appropriate disease specific measure of physical function.	Six weeks
BPI-SF	The BPI pain scale has been widely used and found to provide a reliable and valid measure of pain and pain's interference with physical functioning in seven areas including: general activity, mood, walking ability, work, relations with other people, sleep and enjoyment of life. The instrument consists of a series of 11-point numeric rating scales asking the participant to rate the pain and indicate how much the pain has interfered with seven areas (0 indicating "does not interfere", 10 indicating "completely interferes").	six weeks
PGIC	The Patient Global Impression of Change Scale (PGIC). This measure is a single-item rating by participants of their improvement with treatment on a 7-point scale that ranges from "very much improved' to "very much worse" with "no-change, as the mid-point.	six weeks
PGSS	The Patient Global Satisfaction Scale (PGSS) is a 10-point scale with verbal descriptors ranging from "very satisfied" to "not at all satisfied.	six weeks

Collaborators and Investigators

• Sponsor: Delivra, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Delivra-001