Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
