Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the efficacy of intravenous ibuprofen on reducing fever at 4 hours.

Detailed Description
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The primary objective of this study is to evaluate the efficacy of a single 400 mg dose of intravenous ibuprofen on reducing fever greater than or equal to 101.0ºF (38.3ºC), as compared with the efficacy of parallel placebo treatment.

Official Title
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A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial To Evaluate The Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Adult Febrile Patients

Conditions
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Fever

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Ibuprofen
* Drug: Ibuprofen
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be hospitalized Have new (not chronic, within last 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC) Have adequate intravenous access Have the ability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board), and agree to abide by the study restrictions and to return for the required assessments Exclusion Criteria: Be less than 18 years of age Have received antipyretic drug therapy (e.g., aspirin, other NSAIDs, or acetaminophen) within 4 hours before dosing Have any history of allergy or hypersensitivity to any component of IVIb, NSAIDs (including aspirin), or COX-2 inhibitors Be pregnant or nursing Have a history of severe head trauma that required current hospitalization, intracranial surgery, or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesions Weigh less than 40 kg 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 a platelet count less than 30,000/mm3 Be receiving full dose anticoagulation therapy 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 treatment with corticosteroids (Patients who are expected to receive corticosteroids during the Treatment Period or through Hour 120 of the Post-treatment Period are not eligible.) Have neurogenic fever Be on dialysis, have oliguria or creatinine greater than 3.0 mg/dL, or be receiving nephrotoxic drugs Have had major surgery within the past 12 hours, unless adequate hemostasis has been achieved Have received another investigational drug within the past 30 days Become afebrile (temperature below 101.0ºF [38.3ºC]) before dosing and not redevelop fever entry criteria during this hospitalization Be otherwise unsuitable for the study, in the opinion of the Investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen<br> | Drug: Ibuprofen<br>* Intravenous ibuprofen, 100 mg, Single-dose<br>Drug: Ibuprofen<br>* Intravenous ibuprofen, 200mg, single dose<br>Drug: Ibuprofen<br>* Intravenous ibuprofen, 400 mg, Single-dose<br>|
| Placebo Comparator: Saline<br>Normal Saline | Other: Normal Saline<br>* Normal Saline, 100 ml, Single-dose<br>* Other names: 0.9 % NaCL; 0.9 % Sodium Chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients with fever reduction to less than 101.0 degree fahrenheit following a single dose of intravenous ibuprofen. |  | 4 hours |