Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee

Study Overview
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Brief Summary
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To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.

Official Title
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A Multi-Center, Double-Blind, Vehicle-Controlled, Parallel-Group Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% in the Treatment of Subjects With Osteoarthritis of the Knee

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Diclofenac Sodium Topical Gel, 1%
* Drug: Voltaren Topical Gel, 1%
* Drug: Vehicle Diclofenac Sodium Topical Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee. Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease. After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement for target knee If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study Able to tolerate rescue medication with paracetamol/acetaminophen. Exclusion Criteria: Pregnant or lactating or planning to become pregnant during the study period. X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease. History of OA pain in the contralateral knee requiring medication within 1 year prior to screening. After discontinuing all pain medications for at least 7 days, has a baseline score of ≥20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization. History of secondary OA, rheumatoid arthritis, chronic inflammatory disease or fibromyalgia. History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease. History of gastrointestinal bleeding or peptic ulcer disease. Use of warfarin or other anticoagulant therapy within 30 days of study randomization. Elevated transaminases at screening. Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of study randomization. Concomitant use of corticosteroids or use within 30 days of study randomization. Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis taken for at least 3 months prior to enrollment and maintained throughout the duration of the study. Known allergy to aspirin or nonsteroidal anti-inflammatory drug Any other acute or chronic illness that could compromise the integrity of study data or place the subject at risk by participating in the study. Receipt of any drug as part of a research study within 30 days prior to screening. Previous participation in this study. Any use between screening and baseline of a treatment or medication that may potentially confound study assessment that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs). Recent history of major knee injury or surgery. Known history of positive HIV

Ages Eligible for Study
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Minimum Age: 35 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac Sodium Topical Gel, 1%<br>Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks | Drug: Diclofenac Sodium Topical Gel, 1%<br>* Opaque, white gel<br>|
| Active Comparator: Voltaren Topical Gel, 1%<br>Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks | Drug: Voltaren Topical Gel, 1%<br>* Opaque, white gel<br>|
| Placebo Comparator: Vehicle Diclofenac Sodium Topical Gel<br>Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks | Drug: Vehicle Diclofenac Sodium Topical Gel<br>* Opaque, white gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 4 Weeks in WOMAC Pain Score | Mean change from baseline to week 4 in the Western Ontario McMaster Osteoarthritis (WOMAC) pain score: 5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4 | Baseline and Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee