At a glance
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An Efficacy and Safety Study of Sustained-release Paracetamol in Subjects With Osteoarthritis
In Brief
A Phase 3 clinical trial evaluating Paracetamol 1000 mg SR tablets, Paracetamol 665 mg SR tablets, and 1 other intervention for Pain. Completed, enrolled 960 participants across 56 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.