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

Launched by GLAXOSMITHKLINE · Dec 4, 2014

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Eligibility criteria

• 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