A Study of Caldolor in Hospitalized Febrile Pediatric Patients

NCT00225706 | Completed Phase 3

• 1 other identifier: CPI-CL-005
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Temperature

Interventions

Caldolor DRUG

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Be hospitalized
• Be between 6 months and 17 years of age, inclusive
• 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.)
• 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.)

You may not qualify if:

• Have inadequate intravenous access
• Have received antipyretic drug therapy within 8 hours before dosing
• Be pregnant or nursing
• Have any history of allergy or hypersensitivity to NSAIDs, aspirin, APAP, or any component of Caldolor or APAP.
• 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
• Have a history of febrile convulsion or have a sibling with a history of febrile convulsion
• 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
• Have gastrointestinal bleeding that has required medical intervention within the previous 6 weeks, unless definitive surgery has been performed
• Have platelet count less than 30,000/mm3
• Be receiving full dose anticoagulation therapy (Prophylaxis with subcutaneous heparin is acceptable.)
• Have fever secondary to blood or drug reaction
• Have an expected life span of less than 14 days because of imminent withdrawal of life support or severity of illness
• Be receiving ongoing or imminent treatment with corticosteroids
• Have neurogenic fever
• 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

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (3)

Vanderbilt University Children's Hospital

Nashville, Tennessee, 37203, United States

Location

Hospital Cecilio Castillero

Chitré, Herrera Province, Panama

Location

Unitas Hospital

Lyttleton, Pretoria, 0157, South Africa

Location

MeSH Terms

Conditions

Fever

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 22, 2005
• First Posted: September 26, 2005
• Study Start: October 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: April 12, 2010

Record last verified: 2007-10

Locations

US (1); ZA (1); PA (1)