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

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