A Study of Caldolor in Hospitalized Febrile Pediatric Patients

NCT ID: NCT00225706

Last Updated: 2010-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2007-08-31

Brief 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]).

Conditions

Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Caldolor

Intervention Type: DRUG

Eligibility 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 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Locations

Vanderbilt University Children's Hospital

Nashville, Tennessee, United States

Hospital Cecilio Castillero

Chitré, Herrera Province, Panama

Unitas Hospital

Lyttleton, Pretoria, South Africa

Countries

United States; Panama; South Africa

Other Identifiers

CPI-CL-005

Identifier Type: -

Identifier Source: org_study_id