A Controlled Study of an Herbal Topical Patch in Treating Osteoarthritis (OA) of the Knee

Study Overview
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Brief Summary
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An evaluation of the safety and efficacy of an herbal patch in treating osteoarthritis pain of the right or left knee.

Detailed Description
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This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study of herbal patch in subjects with OA knee pain. The overall objective of this study is to evaluate the efficacy and safety of the patch in relieving OA knee pain.

Official Title
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A Multi-Center, Randomized, Double-Blind, Parallel, Placebo Control Study of a Traditional Chinese Medicine Topical Analgesic Patch in the Treatment of Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Herbal Patch
* Other: Placebo Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between 40 and 70 years of age Medically cleared to participate by a site affiliated physician following a physical History of, or current diagnosis of, OA of the knee Evidence of idiopathic OA of at least one knee Subject Assessment of OA pain in target knee 40 - 75 mm (on the 100 mm VAS inclusive) in the index knee, on the WOMAC Pain composite subscale at Visit 1 Subject Assessment of OA pain in non-index knee (if applicable) is ≤ 20mm Subject Global Assessment of OA Condition (5 pt categorical scale, 1 = very good to 5 = very poor) of grade 3-5 (i.e. fair, poor or very poor) Evidence of idiopathic OA of at least one knee as defined by the American College of Rheumatology Classification (ACR) of OA of the Knee Exclusion Criteria: Grade 1 or Grade 4 severity of the index knee based on the Kellgren and Lawrence radiographic criteria Pain greater than 20 mm on the VAS in the non-index knee (either at rest or with movement) Prior injection or arthroscopy of study knee within 3 months Crystalline-induced synovitis (e.g. gout, pseudo gout, nonsteroid arthritis, hydroxyapatite deposit), acute inflammatory arthritis, rheumatoid arthritis, psoriatic arthritis, septic arthritis, fibromyalgia, systemic lupus, erythematosus collagen vascular disease or other types of inflammatory arthritis in the index knee Pain in either knee is of neurological origin An injury or surgery to the same body region within the prior 6 months or a lifetime history of 3 or more injuries/surgeries to the injured body region Signs of clinically important active inflammation of the study knee joint including redness, warmth, and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits Other criteria that - in the opinion of the investigator - may jeopardize the safety of the subject or the study results.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Patch<br>Herbal Patch | Other: Herbal Patch<br>* 1 herbal patch applied for approximately 8 hours per day for 14 days<br>* Other names: Traditional Chinese Medicine Topical Analgesic Patch;|
| Placebo Comparator: Control Patch<br>Placebo Patch | Other: Placebo Patch<br>* Control patch with no herbal ingredients<br>* Other names: Not a marketed product;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | The WOMAC (Western Ontario and McMaster Universities Index of Osteoarthritis) Pain Subscale Score | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Assessment | Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition | Day 3 | 
| Subject Assessment | Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition | Day 7 | 
| Subject Assessment | Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition | Day 14 | 
| Investigator Assessment | Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index | Day 3 | 
| Investigator Assessment | Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index | Day 7 | 
| Investigator Assessment | Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Pain, Herbal medicine, Topical administration