A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis
Condition: Pain
MeSH terms: Osteoarthritis
Intervention: Paracetamol 1000 mg SR tablets; Paracetamol 665 mg SR tablets; Placebo
Intervention description: Two paracetamol 1000 mg SR tablets administered orally two times a day plus two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day for 12 weeks.; Two paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks.; Two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks.
Intervention MeSH terms: Acetaminophen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 960.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

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 osteoarthritis of the knee or hip.
    

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