Status:
COMPLETED
A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pain
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
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 osteoarthr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
960 Patients enrolled
Trial Details
Trial ID
NCT02311881
Start Date
January 1 2015
End Date
February 1 2016
Last Update
April 7 2017
Active Locations (56)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35242
2
GSK Investigational Site
Huntsville, Alabama, United States, 35801
3
GSK Investigational Site
Chandler, Arizona, United States, 85224
4
GSK Investigational Site
Tucson, Arizona, United States, 85712