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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: Topical Arthritis Cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical Arthritis Cream<br>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<br> <br> * Other names: LivRelief Pharmax Rebuild;|
| Placebo Comparator: Placebo<br>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<br> <br> * Other names: LivRelief Pharmax Rebuild;|

What is the study measuring?
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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 |