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A Study of Caldolor in Hospitalized Febrile Pediatric Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00225706
First Posted: September 26, 2005
Last Update Posted: April 12, 2010
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.
Information provided by:
Cumberland Pharmaceuticals
  Purpose
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]).

Condition Intervention Phase
Fever Drug: Caldolor Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Caldolor in Hospitalized Febrile Pediatric Patients

Resource links provided by NLM:


Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • Temperature

Study Start Date: October 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225706


Locations
United States, Tennessee
Vanderbilt University Children's Hospital
Nashville, Tennessee, United States, 37203
Panama
Hospital Cecilio Castillero
Chitre, Herrera, Panama
South Africa
Unitas Hospital
Lyttleton, Pretoria, South Africa, 0157
Sponsors and Collaborators
Cumberland Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00225706     History of Changes
Other Study ID Numbers: CPI-CL-005
First Submitted: September 22, 2005
First Posted: September 26, 2005
Last Update Posted: April 12, 2010
Last Verified: October 2007

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action