A Study of Caldolor in Hospitalized Febrile Pediatric Patients

Fever Clinical Trial

Official title:

Efficacy and Safety Study of Caldolor in Hospitalized Febrile Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225706
• Other study ID #: CPI-CL-005
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2005
• Last updated: April 8, 2010
• Start date: October 2005
• Est. completion date: August 2007

Study information

• Verified date: October 2007
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 17 Years

Eligibility

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 Caldolor 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fever

Intervention

Drug:
• Caldolor

Locations

Country	Name	City	State
Panama	Hospital Cecilio Castillero	Chitre	Herrera
South Africa	Unitas Hospital	Lyttleton	Pretoria
United States	Vanderbilt University Children's Hospital	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Countries where clinical trial is conducted

United States,  Panama,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature