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Sponsored by: |
Cumberland Pharmaceuticals |
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Information provided by: | Cumberland Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00225706 |
The primary objective of this study of Amelior administered to febrile hospitalized pediatric patients every 6 hours for 24 hours is to determine the clinical equivalence of a single dose of Amelior 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]).
Condition | Intervention | Phase |
---|---|---|
Fever |
Drug: Amelior |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Efficacy and Safety Study of Amelior in Hospitalized Febrile Pediatric Patients |
Ages Eligible for Study: | 6 Months to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt University Children's Hospital | |
Nashville, Tennessee, United States, 37203 | |
Panama, Herrera | |
Hospital Cecilio Castillero | |
Chitre, Herrera, Panama | |
South Africa, Pretoria | |
Unitas Hospital | |
Lyttleton, Pretoria, South Africa, 0157 |
Study ID Numbers: | CPI-CL-005 |
Study First Received: | September 22, 2005 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00225706 |
Health Authority: | United States: Food and Drug Administration |
Fever |