CLINICAL TRIALS PROFILE FOR CALDOLOR
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All Clinical Trials for CALDOLOR
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00225706 ↗ | 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]). |
| NCT00225732 ↗ | 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 |
| NCT00470600 ↗ | 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. |
| NCT00606489 ↗ | 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. |
| NCT01200069 ↗ | IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia | Terminated | Rutgers, The State University of New Jersey | Phase 4 | 2010-07-01 | Post-procedure myalgia (muscle ache) is a well-known and common complication of Electro-convulsive Treatment (ECT). Myalgias are a serious concern of patients and occur in approximately 50% of these cases. The pain is usually described as muscle soreness, similar to that resulting from strenuous exercise. The myalgias typically begin shortly after the procedure, lasting approximately 2-7 days in total. A recent study reported that 89% of patients considered prevention significant and would be willing to pay a median of $33 out of pocket to avoid this side effect. In addition to patient discomfort, myalgias can have a further financial burden if these patients are unable to return to work or resume previous daily activities in the days following the procedure. An agent that could treat and possibly even prevent these myalgias has the potential to be very beneficial to these patients. IV ibuprofen (trade name Caldolor) is a novel therapeutic modality approved by the US Food and Drug Administration (FDA) in June 2009 for the treatment of mild to moderate pain, as an adjunct to opioid analgesics, and for the reduction of fever. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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