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

Further Study Details: 

Primary Outcomes: Temperature

Ages Eligible for Study:  6 Months   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Be hospitalized
2. Be between 6 months and 17 years of age, inclusive
3. Have new (not chronic, within last 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC) (The preferred method of temperature measurement is core. The route of temperature measurement used immediately before randomization should be used immediately before dosing and for all temperature measurements during the Treatment Period.)
4. Have written informed consent provided by legal parent, guardian, or authorized agent, and have same agree to abide by the study restrictions and to return for the required assessments (Where appropriate, participants of appropriate intellectual maturity should personally provide written informed assent; age of assent may be determined by Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs) or be consistent with local legal requirements.)

Exclusion Criteria:

1. Have inadequate intravenous access
2. Have received antipyretic drug therapy within 8 hours before dosing
3. Be pregnant or nursing
4. Have any history of allergy or hypersensitivity to NSAIDs, aspirin, APAP, or any component of Amelior or APAP.
5. Have a history of severe head trauma that required the current hospitalization, had intracranial surgery or stroke within the previous 30 days, or have any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesions
6. Have a history of febrile convulsion or have a sibling with a history of febrile convulsion
7. Have a history of congenital bleeding diatheses (e.g., hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction, including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction
8. Have gastrointestinal bleeding that has required medical intervention within the previous 6 weeks, unless definitive surgery has been performed
9. Have platelet count less than 30,000/mm3
10. Be receiving full dose anticoagulation therapy (Prophylaxis with subcutaneous heparin is acceptable.)
11. Have fever secondary to blood or drug reaction
12. Have an expected life span of less than 14 days because of imminent withdrawal of life support or severity of illness
13. Be receiving ongoing or imminent treatment with corticosteroids
14. Have neurogenic fever
15. Be on dialysis, have oliguria or calculated creatinine clearance of less than 70 mL/min (calculated using the Schwartz formula), have impaired renal function, be receiving nephrotoxic drugs, or be expected to be unable to tolerate the extra fluid required for administration of CTM
16. Have had major surgery within the past 12 hours, unless adequate hemostasis has been achieved
17. Have received another investigational drug within the past 30 days
18. Be otherwise unsuitable for the study, in the opinion of the Investigator

Please refer to this study by ClinicalTrials.gov identifier  NCT00225706

Amy D Rock, PhD      615-255-0068  Ext. 243    arock@cumberlandpharma.com

Tennessee
      Vanderbilt University Children''''s Hospital, Nashville,  Tennessee,  37203,  United States

Study ID Numbers:  CPI-CL-005
Last Updated:  September 23, 2005
Record first received:  September 22, 2005
ClinicalTrials.gov Identifier:  NCT00225706
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27