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
The CPI-CL-004 study report did not include results for the number and percentage of
treatment failures at 24 h or for the time to treatment failure according to illness severity
stratum. The ISE did report stratified results for these outcomes but the ISE analyses used
a definition of treatment failure that differed from the one that was specified in the CPI-CL-
004 study protocol.
Figure 2. CPI-CL-004: Core body temperature over time, ITT population.
Caldolor 400 mg was superior to placebo in respect of all but one of the other prespecified
efficacy outcomes (time to treatment failure, which showed a non-significant increase in
favour of Caldolor 400 mg).
In the Caldolor 100 mg and 200 mg groups, the percentage of patients with fever
reduction 4 h after the first dose (an outcome that corresponds to the primary outcome in
the 400 mg dose group), was significantly higher than in the placebo group, using a critical
p-value of 0.05 (Table 11).
Table 11. CPI-CL-004: Outcomes in the Caldolor 100 mg and 200 mg q4h dose groups that
correspond to the primary outcome in the Caldolor 400 mg q4h dose group - ITT population.
Temp