To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:35 - Any
Updated:7/8/2016
Start Date:August 2015
End Date:May 2016

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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis Consumer Health, Inc) in Patients With Osteoarthritis (OA) of the Knee

This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site
Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1%
(Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis
Consumer Health, Inc) in Patients with Osteoarthritis (OA) of the Knee


Inclusion Criteria:

1. Healthy male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of OA
of the knee according to the American College of Rheumatology (ACR) criteria.

2. OA Symptoms for at least 6 months prior to screening.

3. Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of > 9 on a 20
point scale for the target knee immediately prior to randomization.

Exclusion Criteria:

1. History of OA pain in the contralateral knee requiring medication within 1 year prior
to screening.

2. History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g.,
colitis) or fibromyalgia.

3. History of gastrointestinal bleeding or peptic ulcer disease.

4. Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).

5. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or
methotrexate prior to 30 days of screening.

6. Concomitant use of systemic corticosteroids, topical corticosteroids, or
immunosuppressive drugs or their use prior to 30 days of screening.
We found this trial at
44
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1181
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Wichita, KS
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Altoona, Pennsylvania
2203
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Altoona, PA
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Anaheim, California
17
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Anaheim, CA
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Anaheim, California
17
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Anaheim, California
17
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Anaheim, CA
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1423
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Beaumont, TX
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1185
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Bryan, TX
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Canoga Park, California
34
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Canoga Park, CA
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Carlsbad, California
73
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Carlsbad, CA
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Carmichael, California
364
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Carmichael, CA
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Cerritos, California
15
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Cerritos, CA
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Charlottesville, Virginia
2208
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Charlottesville, VA
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202
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Dallas, CA
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El Cajon, California
107
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El Cajon, CA
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1891
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Englewood, OH
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Evanston, Illinois
1728
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Evanston, IL
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Fort Lauderdale, Florida
2315
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Fort Lauderdale, FL
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2314
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Hialeah, FL
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1357
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Houston, TX
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1357
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Houston, TX
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1057
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Knoxville, TX
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La Mesa, California
106
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La Mesa, CA
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1171
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Lampasas, TX
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358
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Mesa, AZ
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2322
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Miami, FL
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2322
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Miami, FL
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2322
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Miami, FL
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2322
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Miami, FL
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2322
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Miami, FL
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Miami Lakes, Florida
2311
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Miami Lakes, FL
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Midlothian, Virginia
2257
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Midlothian, VA
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Nashville, Tennessee
1763
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Nashville, TN
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New Orleans, Louisiana
1656
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New Orleans, LA
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Newburgh, Indiana 47630
1723
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Newburgh, IN
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Ormond Beach, Tennessee
1778
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Ormond Beach, TN
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Pasadena, California
9
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Pasadena, CA
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Rancho Cucamonga, California
24
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Rancho Cucamonga, CA
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Sacramento, California
366
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Sacramento, CA
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1859
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Sagniaw, MI
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San Antonio, Texas
1188
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San Antonio, TX
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San Antonio, Texas
1188
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San Antonio, TX
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St. Louis, Missouri
1573
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St. Louis, MO
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West Palm Beach, Florida
2304
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West Palm Beach, FL
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West Palm Beach, Florida
2304
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West Palm Beach, FL
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