Conditions: Post-operative Pain
Keywords: Dental pain Ibuprofen Acetaminophen Nurofen Plus® Panadeine® Extra Paracetamol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 678
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet arm 2: Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg arm 3: Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) arm 4: Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) arm 5: Two placebo tablets

Interventions: intervention 1: Ibuprofen/acetaminophen intervention 2: Ibuprofen/acetaminophen (higher dose) intervention 3: Nurofen Plus® intervention 4: Panadeine® Extra intervention 5: Placebo
Intervention descriptions: intervention 1: One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water intervention 2: Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water intervention 3: Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water intervention 4: Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water intervention 5: Two placebo tablets, single dose taken orally with 300 ml water

Protocol document: