A study comparing the effects of different paracetamol and ibuprofen combination doses and placebo

The test product Maxigesic (a combination of paracetamol 500 mg and ibuprofen 150 mg per tablet) has been on the market since Oct 2009 with Medsafe’s approval. The unit dose determined in each tablet is compliant with the maximum OTC dose for each ingredient as per New Zealand regulatory requirements. However, the side effects of each ingredient are dose related which means taking a higher dose may increase the chance of experiencing adverse effects. Recent regulatory reassessments of NSAIDs in some areas have encouraged treatment to be at the lowest effective dose and as short as possible because of the twin risks of GI bleeding and newly identified thromboembolic events. Therefore, it is important to determine the dose response relationship of this combination to allow more definitive dosing recommendations to be made and limit the risk of experiencing adverse effects. The primary study hypothesis is the pain relief effects of these three different combination doses and placebo administered will form a dose response curve.