A Study of Caldolor in Hospitalized Febrile Pediatric Patients
Completed
Cumberland Pharmaceuticals
Phase 3
2005-10-01
The primary objective of this study of Caldolor administered to febrile hospitalized
pediatric patients every 6 hours for 24 hours is to determine the clinical equivalence of a
single dose of Caldolor compared to acetaminophen (paracetamol; APAP) for the treatment of
fever as measured by the AUC Tº within the first 6 hours of treatment (as compared to a
target temperature of 98.6ºF [37.0ºC]).
Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients
Completed
Cumberland Pharmaceuticals
Phase 3
2005-01-01
The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative
hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of
Caldolor compared to placebo for the treatment of post-operative pain as measured by
reduction in the requirement for the narcotic analgesic, morphine, post surgery
Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients
Completed
Cumberland Pharmaceuticals
Phase 3
2007-05-01
The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative
hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine
the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of
post-operative pain by patients self-assessment of pain.
Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients
Completed
Cumberland Pharmaceuticals
Phase 3
2007-11-01
The primary objective of this study of Caldolor administered to hospitalized adult and
pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when
compared to placebo when administered every 6 hours for at least 24 hours.
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