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
sites
Charlottesville, Virginia 22911
2208
mi
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Charlottesville, VA
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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1787
mi
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Birmingham, AL
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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2176
mi
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DeLand, FL
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175 Meadowbrook Lane
, Pennsylvania 16635
814-693-0300
2201
mi
from 91732
, PA
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4460 Red Bank Expressway
Cincinnati, Ohio 45227
513-721-3868
1885
mi
from 91732
Cincinnati, OH
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4085 University Blvd S # 1
Jacksonville, Florida 32216
2134
mi
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Jacksonville, FL
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2080 Bridgeport Avenue
Milford, Connecticut 06460
203-386-3115
2479
mi
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Milford, CT
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4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
1182
mi
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San Antonio, TX
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611 NE Main Street
Simpsonville, South Carolina 29681
864-962-0431
2027
mi
from 91732
Simpsonville, SC
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
1186
mi
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Wichita, KS
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Austin, Texas 78705
1209
mi
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Austin, TX
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Brockton, Massachusetts 02301
2581
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Brockton, MA
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Carmichael, California 95608
364
mi
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Carmichael, CA
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Cincinnati, Ohio 45219
1879
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Cincinnati, OH
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Cincinnati, Ohio 45255
1880
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Cincinnati, OH
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Columbus, Ohio 43212
1958
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Columbus, OH
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Crestview Hills, Kentucky 41017
1876
mi
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Crestview Hills, KY
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Fleming Island, Florida 32003
2131
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Fleming Island, FL
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Florissant, Missouri 63031
1566
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Florissant, MO
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Greensboro, North Carolina 27408
2150
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Greensboro, NC
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Greer, South Carolina 29651
2027
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Greer, SC
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Hartsdale, New York 10530
2442
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Hartsdale, NY
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Jacksonville, Florida 32205
2130
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Jacksonville, FL
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Kettering, Ohio 45429
1899
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Kettering, OH
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Las Vegas, Nevada 89144
210
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Las Vegas, NV
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2318
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Miami, FL
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Omaha, Nebraska 68134
1295
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Omaha, NE
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Omaha, Nebraska 68134
1295
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Omaha, NE
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Ormond Beach, Florida 32174
2186
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Ormond Beach, FL
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Pismo Beach, California 93449
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Pismo Beach, CA
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1227
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Plano, TX
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Ponte Vedra, Florida 32081
2149
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Ponte Vedra, FL
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Prairie Village, Kansas 66206
1337
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Prairie Village, KS
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Roanoke, Virginia 24018
2133
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Roanoke, VA
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San Antonio, Texas 78209
1189
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San Antonio, TX
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St. Louis, Missouri 63141
1559
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St. Louis, MO
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Traverse City, Michigan 49684
1864
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Traverse City, MI
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1962
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Troy, MI
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1180
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Wichita, KS
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