Study of Meloxicam Capsules to Treat Osteoarthritis Pain



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - Any
Updated:5/27/2013
Start Date:February 2013
End Date:November 2013
Contact:Alexis Gomez
Email:agomez@iroko.com
Phone:267-546-1426

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A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy, and Safety Study of Meloxicam SoluMatrix™ Capsules in Patients With Pain Due to Osteoarthritis of the Knee or Hip


The purpose of this study is to determine whether Meloxicam [Test] Capsules are safe and
effective for the treatment of osteoarthritis pain of the knee or hip.


Inclusion Criteria:

- Primary diagnosis of Functional Class I-III OA of the hip or knee

- Chronic user of nonsteroidal anti-inflammatory drugs (NDAIDs) and/or acetaminophen
for OA pain

- Discontinued all analgesic therapy at Screening

- For women of child-bearing potential: a woman who is not pregnant and not nursing,
and who is practicing an acceptable method of birth control

Exclusion Criteria:

- History of allergic reaction or clinically significant intolerance to acetaminophen,
aspirin, or any NSAIDs, including meloxicam

- Requires continuous use of opioid or opioid combination products to control OA pain
of the knee or hip

- Clinically significant unstable cardiac, respiratory, neurological, immunological,
hematological, or renal disease

- Significant difficulties swallowing capsules or unable to tolerate oral medication

- Previous participation in another clinical study of Meloxicam Capsules or received
any investigational drug or device or investigational therapy within 30 days before
Screening
We found this trial at
39
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Jacksonville, Florida 32205
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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175 Meadowbrook Lane
, Pennsylvania 16635
814-693-0300
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4460 Red Bank Expressway
Cincinnati, Ohio 45227
513-721-3868
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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2080 Bridgeport Avenue
Milford, Connecticut 06460
203-386-3115
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4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
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611 NE Main Street
Simpsonville, South Carolina 29681
864-962-0431
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Austin, Texas 78705
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Brockton, Massachusetts 02301
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Carmichael, California 95608
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Charlottesville, Virginia 22911
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Cincinnati, Ohio 45219
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Cincinnati, Ohio 45255
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Columbus, Ohio 43212
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Crestview Hills, Kentucky 41017
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Fleming Island, Florida 32003
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Florissant, Missouri 63031
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Greensboro, North Carolina 27408
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Greer, South Carolina 29651
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Hartsdale, New York 10530
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Kettering, Ohio 45429
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Las Vegas, Nevada 89144
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Omaha, Nebraska 68134
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Omaha, Nebraska 68134
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Ormond Beach, Florida 32174
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Pismo Beach, California 93449
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Ponte Vedra, Florida 32081
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Prairie Village, Kansas 66206
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Roanoke, Virginia 24018
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San Antonio, Texas 78209
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St. Louis, Missouri 63141
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Traverse City, Michigan 49684
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