A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis



Status:Completed
Conditions:Chronic Pain, Osteoarthritis (OA)
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:40 - 80
Updated:4/21/2016
Start Date:January 2015
End Date:February 2016

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An Efficacy and Safety Study of Sustained-release Paracetamol in Subjects With Osteoarthritis

The purpose of the study is to determine whether paracetamol 1000 mg sustained-release (SR)
tablets administered orally, twice daily are effective and safe in the treatment of patients
with osteoarthritis of the knee or hip.


Inclusion Criteria:

- Male or female participants between 40 and 80 years of age

- Diagnosis of moderate to moderately-severe osteoarthritis (OA) of either the knee or
hip with respect to the following:

- Pain in one knee/hip over 3 months immediately before screening visit

- Use of non steroidal anti-inflammatory drugs (NSAIDs), acetaminophen
(paracetamol) or any other analgesic for 3 or more days per week for at least 3
months prior to screening visit

- Clinical diagnosis of osteoarthritis of knee/hip for minimum 6 month duration
prior to screening visit

- Therapeutic benefit with acetaminophen use with a score of ≥ 1 on 5-point
categorical scale

- Radiological evidence of ≥ Grade 2 osteoarthritis according to Kellgren-Lawrence
radiographic criteria

- Increased WOMAC Pain Subscale score of at least 20 % following untreated run-in
period

- Moderate to moderately-severe self-reported pain on a 5-point categorical scale
following untreated run-in period

- Historical self-reported positive therapeutic benefit with paracetamol use for
osteoarthritis pain relief

Exclusion Criteria:

- History of surgery or major trauma to the study joint

- Clinically significant signs or symptoms of inflammation upon completion of run-in
period

- Required ongoing use of analgesic therapy for other indications, anticoagulants,
psychotherapeutic agents, aspirin at daily doses greater than 325 mg, statin-class
hypolipidemic agents at doses that have not been stabilized, or other treatments know
to interfere with pain perception

- History of hepatic or renal or liver or biliary disease or gastrointestinal surgery

- Participants with alanine aminotransferase (ALT) >2 times Upper Limit Normal (2xULN)
and bilirubin > 1.5 times Upper Limit Normal (1.5xULN) (However, if direct bilirubin
is <35% and fractioned, isolated bilirubin >1.5xULN is acceptable)

- Other arthritis type, fibromyalgia or collagen vascular disease or secondary OA of
study joint or chronic pain condition
We found this trial at
54
sites
Mount Pleasant, South Carolina 29464
Phone: 877-379-3718
525
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Mount Pleasant, SC
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Altoona, Pennsylvania 16602
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247
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Anaheim, California 92807
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1953
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Bellevue, Nebraska 68123
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680
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Birmingham, Alabama 35249
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493
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Brandon, Florida 33511
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834
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Brooklyn, New York 11215
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Buffalo, New York 14263
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Carmichael, California 95608
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Chandler, Arizona 85224
Phone: 877-379-3718
1655
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Chicago, Illinois 60611
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Cincinnati, Ohio 45229
Phone: 877-379-3718
96
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Cincinnati, Ohio 45229
96
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Cincinnati, Ohio 45229
96
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Clearwater, Florida 33759
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828
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Crestview Hills, Kentucky 41017
Phone: 877-379-3718
105
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Dallas, Texas 75230
Phone: 877-379-3718
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Dayton, Ohio 45420
60
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Duncansville, Pennsylvania 16635
Phone: 877-379-3718
244
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Edgewater, Florida 32132
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768
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Evanston, Illinois 60201
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283
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Fresno, California 93720
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Hartsdale, New York
489
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Hialeah, Florida 33013
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Hialeah, Florida 33013
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Hickory, North Carolina 28601
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306
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Homestead, Florida 33030
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Huntsville, Alabama 35801
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Jupiter, Florida 33458
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Las Vegas, Nevada 89102
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Miami, Florida 33136
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New Orleans, Louisiana 70112
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North Hollywood, California 91606
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Oklahoma, Oklahoma 73119
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Oldsmar, Florida 34677
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Omaha, Nebraska 68131
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Orlando, Florida 32806
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Oviedo, Florida 32765
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Plano, Texas 75093
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Port Orange, Florida 32129
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Prairie Village, Kansas 66208
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Saint Louis, Missouri 63110
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San Antonio, Texas 78258
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San Antonio, Texas 78258
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San Diego, California 92111
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Savannah, Georgia 31405
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Smithfield, Pennsylvania 15478
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South Miami, Florida 33143
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Toledo, Ohio 43608
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Tucson, Arizona 85724
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Tucson, Arizona 85724
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Watertown, Massachusetts 02472
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West Palm Beach, Florida 33409
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Wichita, Kansas 67207
780
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