A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis
NCT ID: NCT02311881
Last Updated: 2017-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
960 participants
INTERVENTIONAL
2015-01-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Paracetamol 2000 mg twice daily (BID)
Participants will be instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (\~ 240 mL) of water/dose for 12 weeks.
Paracetamol 1000 mg SR tablets
Two paracetamol 1000 mg SR tablets administered orally two times a day plus two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day for 12 weeks.
Paracetamol 1330 mg thrice daily (TID)
Participants will be instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces (\~ 240 mL) of water/dose for 12 weeks.
Paracetamol 665 mg SR tablets
Two paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks.
Placebo
Participants will be instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (\~ 240 mL) of water/dose for 12 weeks.
Placebo
Two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks.
Interventions
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Paracetamol 1000 mg SR tablets
Two paracetamol 1000 mg SR tablets administered orally two times a day plus two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day for 12 weeks.
Paracetamol 665 mg SR tablets
Two paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks.
Placebo
Two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Huntsville, Alabama, United States
GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Carmichael, California, United States
GSK Investigational Site
Fresno, California, United States
GSK Investigational Site
North Hollywood, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Brandon, Florida, United States
GSK Investigational Site
Clearwater, Florida, United States
GSK Investigational Site
Edgewater, Florida, United States
GSK Investigational Site
Hialeah, Florida, United States
GSK Investigational Site
Hialeah, Florida, United States
GSK Investigational Site
Homestead, Florida, United States
GSK Investigational Site
Jupiter, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Oldsmar, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Oviedo, Florida, United States
GSK Investigational Site
Port Orange, Florida, United States
GSK Investigational Site
South Miami, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Savannah, Georgia, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Evanston, Illinois, United States
GSK Investigational Site
Prairie Village, Kansas, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Crestview Hills, Kentucky, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
Watertown, Massachusetts, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Bellevue, Nebraska, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Brooklyn, New York, United States
GSK Investigational Site
Buffalo, New York, United States
GSK Investigational Site
Hartsdale, New York, United States
GSK Investigational Site
Hickory, North Carolina, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Dayton, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
GSK Investigational Site
Altoona, Pennsylvania, United States
GSK Investigational Site
Duncansville, Pennsylvania, United States
GSK Investigational Site
Smithfield, Pennsylvania, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Plano, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
Countries
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Other Identifiers
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RH02448
Identifier Type: OTHER
Identifier Source: secondary_id
202195
Identifier Type: -
Identifier Source: org_study_id
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