A Study of Caldolor in Hospitalized Febrile Pediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00225706
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : April 12, 2010
Information provided by:
Cumberland Pharmaceuticals

September 22, 2005
September 26, 2005
April 12, 2010
October 2005
August 2007   (Final data collection date for primary outcome measure)
Same as current
Complete list of historical versions of study NCT00225706 on Archive Site
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A Study of Caldolor in Hospitalized Febrile Pediatric Patients
Efficacy and Safety Study of Caldolor in Hospitalized Febrile Pediatric Patients
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]).
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Caldolor
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2007
August 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Panama,   South Africa,   United States
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Cumberland Pharmaceuticals
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Cumberland Pharmaceuticals
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP