Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis

Study Overview
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Brief Summary
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Osteoarthritis (OA) is the most common form of arthritis. It can cause pain, swelling, and reduced motion in the joints. That can reduce quality of life. OA can occur in any joint, but usually affects the hands, knees, hips or spine. The purpose of this study is to find out if doctors might be able to use 2% PENNSAID gel to treat OA in the knee.

Official Title
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A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Clinical Study to Evaluate the Safety and Efficacy of PENNSAID Gel in the Symptomatic Treatment of Osteoarthritis of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: PENNSAID Gel
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary osteoarthritis of the knee Radiologic evidence of OA of the knee On stable pain therapy with an oral or topical NSAID or acetaminophen Experience a moderate flare of pain following washout of stable pain therapy Able to read and understand English or Spanish to answer pain assessment questions without any explanation If female, surgically sterile or non-pregnant Except for OA, in reasonably good general health Written informed consent Exclusion Criteria: Secondary OA of the study knee History of pseudo gout or inflammatory flare-ups Participation would conflict with contraindications, warnings or precautions as stated in the prescribing information for oral or topical diclofenac Severe, uncontrolled cardiac, renal, hepatic, or other systemic disease Any malignancy within the previous 3 years, except local therapy for superficial skin cancer not on the study knee Known sensitivity to the use of oral or topical diclofenac, aspirin [acetylsalicylic acid (ASA)] or any other NSAID, dimethyl sulfoxide (DMSO), or ethanol Ongoing abnormality that could confound interpretation of the safety results (eg, anemia, unresponsive gastrointestinal [GI] reflux, etc.) Documented gastroduodenal ulcer or any GI bleeding (except hemorrhoidal) within the last 6 months Uncontrolled diabetes Screening laboratory test results of serum creatinine ≥ 1.5 times upper limit of normal; aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyltransferase (GGT) ≥ 3 times upper limit of normal; and hemoglobin less than or equal to lower limit of normal Documented alcohol or drug abuse within 1 year If female, breast-feeding Major surgery or previous damage to the study knee at any time, or minor knee surgery to the study knee within 1 year Requires oral or intra-muscular corticosteroids, or received an intra articular corticosteroid injection into the study knee within the past 90 days, or into any other joint within the past 30 days, or currently applying topical corticosteroids onto the study knee Received intra-articular viscosupplementation (eg, hylan G-F 20 [Synvisc®]) in the study knee in the past 6 months On prior stable therapy (ie, more than 3 days per week for the previous month) with an opioid analgesic prior to the screening visit will be excluded. Recently started taking a sedative hypnotic medication for insomnia Taking anti-depressants Not willing to discontinue prohibited medications/therapies Cannot tolerate acetaminophen Re-entering study after dropping out or withdrawn from study Used another investigational drug within the previous 30 days On or currently applying for disability benefits on the basis of knee OA History of fibromyalgia Other painful or disabling conditions affecting the knee or leg, or disabling condition of the hands (used to apply the study drug) Skin disorder with current involvement on the hands (used to apply the study drug) or the knee(s) (application site) Referred to an orthopedic surgeon for consideration of, or been advised to have, knee replacement or knee reconstruction surgery Radiologic evidence of OA of the knee advanced to the point that all cartilage has been eroded (ie, bone on bone) Recently started using a cane within the past 30 days History of chronic headaches that may require more than occasional use of rescue medication for headaches

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 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: PENNSAID Gel<br>Diclofenac sodium 2.0% w/w | Drug: PENNSAID Gel<br>* 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks<br>* Other names: diclofenac sodium 2.0% w/w;|
| Placebo Comparator: Vehicle<br>The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium | Drug: Vehicle<br>* 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain When Walking On A Flat Surface | Participants rate their pain intensity when walking on a flat surface as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented. | at Baseline | 
| Pain When Walking On A Flat Surface | Participants rate their pain intensity when walking on a flat surface as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented. | at Week 4 | 
| Pain When Going Up Or Down Stairs | Participants rate their pain intensity when going up or down stairs as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented. | at Baseline | 
| Pain When Going Up Or Down Stairs | Participants rate their pain intensity when going up or down stairs as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented. | at Week 4 | 
| Pain At Night While In Bed | Participants rate their pain intensity at night while in bed as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented. | at Baseline | 
| Pain At Night While In Bed | Participants rate their pain intensity at night while in bed as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented. | at Week 4 | 
| Pain While Sitting Or Lying Down | Participants rate their pain intensity while sitting or lying down as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented. | at Baseline | 
| Pain While Sitting Or Lying Down | Participants rate their pain intensity while sitting or lying down as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented. | at Week 4 | 
| Pain While Standing | Participants rate their pain intensity while standing as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented. | at Baseline | 
| Pain While Standing | Participants rate their pain intensity while standing as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented. | at Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Arthritis, NSAIDs, Topical NSAID, Diclofenac, PENNSAID