Post-operative Pain Clinical Trial
Official title:
A Double-blind, 5 Parallel-group, Placebo-controlled, Randomised, Single Dose, 3-site Study to Compare the Analgesic Efficacy and Tolerability of a Combination of Ibuprofen 400 mg Plus Paracetamol 1000 mg; a Combination of Ibuprofen 200 mg Plus Paracetamol 500 mg; a Combination of Ibuprofen 400 mg Plus Codeine 25.6 mg (Nurofen Plus®); a Combination of Paracetamol 1000 mg Plus Codeine 30 mg (Panadeine® Extra) in Postoperative Adult Dental Pain Following Third Molar Extraction.
The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra.
RB has developed a fixed-dose combination of ibuprofen and acetaminophen (paracetamol). Since
the pharmacological actions of ibuprofen and acetaminophen (paracetamol) differ in their site
and mode of action, the combination would be expected to be more effective than either active
alone, given that pain is multi-factorial with different mediators.
The purpose of this study was to compare the efficacy and tolerability of
ibuprofen/acetaminophen (paracetamol) combination with leading market analgesics.
The efficacy and tolerability was assessed in terms of total analgesic effect, peak analgesic
effect, onset and duration of action and the subject's overall assessment of the study
medication.
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