Australian public assessment for Ibuprofen - Therapeutic Goods ...

AusPAR Caldolor Ibuprofen Phebra Pty Ltd PM-2010-02393-3-1
Final 2 January 2013
Therapeutic Goods Administration
Figure 3. CPI-CL-006: Core body temperature from 0 to 72 h after the first dose of
study treatment, ITT population.
Caldolor produced a statistically significant reduction, compared to placebo, in the
primary outcome of AUC-T0-24. The magnitude of the reduction was less than the
anticipated value of 12°C×h but this is not important because the clinical relevance of any
amount of temperature reduction (in terms of eventual patient outcomes) is unknown.
Results for other efficacy outcomes
Caldolor 400 mg significantly reduced area above the temperature 37.0°C (98.6°F) versus
time curve from 0 to 4 h after the start of treatment (AUC-T0-4) and area above the
temperature 37.0°C (98.6°F) versus time curve from 0 to 72 h after the start of treatment
(AUC-T0-72) but had no effect on area above the temperature 37.0°C (98.6°F) versus time
curve from 24 to 72 h after the start of treatment (AUC-T24-72). Caldolor significantly
reduced the time to temperature