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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT02311881

Run by

GlaxoSmithKline

People needed

960

Starts

2015-01-01

Expected to finish

2016-02-01

Last updated by the study team

2017-04-07

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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