Tolerability study of Maxigesic in patients with Mild to Severe Pain
Maxi-Analgesic Tolerability Study: Open-Label, Phase IV, Multi-Centre Clinical Trial to Evaluate the Safety and Tolerability of Maxigesic in Patients with Mild to Severe Pain.
AFT Pharmaceuticals Ltd
600 participants
Oct 1, 2010
Interventional
Conditions
Summary
Both paracetamol and ibuprofen are relatively safe when administered at over the counter (OTC) dose and their safety profile has been well-estabilished for many years. A combination of paracetamol and ibuprofen has been proved to be more effective than each individual component in a phase 3 clinical trial in an acute pain model (ACTRN:12606000291583). However, the safety observation in the same trial is only for 48 hours. In many clinical circumstances, the pain relief period is required to be up to 14 days such as post-operative pain relief for some moderate surgery. At the same time, it is proposed to observe the safety profile for long term use (up to 3 months) in patients with chronic pain.
Eligibility
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Interventions
Interventions: The combination of paracetamol and ibuprofen (paracetamol 500 mg + ibuprofen 150 mg per tablet) Treatment Period: Acute Pain Treatment group: 2 tablets every 6 hours for a minimum of 48 hours to 14 days Chronic Pain Treatment group: Fixed dosing group: 2 tablets every 6 hours between 15 days and 3 months Flexible dosing group: 1-2 tablets every 4 or 6 hours up to a maximum of 8 tablets per day between 15 days and 3 months
Locations(1)
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ACTRN12610000598088