fever
Conditions
Interventions
Product Name: COLDOLOR (Ibuprofen)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ibuprofen
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration
Sponsors
Cumberland Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Parent or Legal Guardian able to provide written Informed Consent prior to participation in the study 2. Be between birth (28 weeks to 101.0°F Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inadequate IV access 2. Have received antipyretic drug therapy within 2 hours before dosing 3. Have any history of allergy or hypersensitivity to NSAIDs, aspirin, or APAP 4. Have received another investigational drug within the past 30 days 5. Be otherwise unsuitable for the study, in the opinion of the Investigator 6. Fever due to Hyperthermia 7. Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the superiority of a single dose of intravenous ibuprofen compared to APAP (oral solution or suppository) for the treatment of fever as measured by the area under the change in temperature versus time cure during the first 30 minutes of treatment;Secondary Objective: To evaluate the change in temperature in patients receiving intravenous ibuprofen and APAP after the first 30 minutes of treatment,60 minutes,4 hours and 24 hours.To evaluate the time to afebrility (temperature less than 38°C (100,4°F).To evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered approximately 10 minutes ;Primary end point(s): Efficacy: AUC0-2, the area under the change in temperature versus time curve from baseline (Study Hour 0) to 2 hours after the start of the initial dose of clinical trial material (Study Hour 2) Safety: Safety will be evaluated on the basis of the following assessments: -vital signs -Clinical chemistry -Treatment-emergent Aes Pharmacokinetic: parameters, including clearance, volume of distribution, elimination T1/2, Cmax, and AUC will be determinate from analysis of collected blood samples ;Timepoint(s) of evaluation of this end point: AUC0-2, the area under the change in temperature versus time curve from baseline (Study Hour 0) to 2 hours after the start of the initial dose of clinical trial material (Study Hour 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: Safety will be evaluated on the basis of the following assessments: -vital signs -Clinical chemistry -Treatment-emergent Aes Pharmacokinetic: parameters, including clearance, volume of distribution, elimination T1/2, Cmax, and AUC will be determinate from analysis of collected blood samples ;Timepoint(s) of evaluation of this end point: Safety: Safety will be evaluated on the basis of the following assessments: -vital signs -Clinical chemistry -Treatment-emergent Aes Pharmacokinetic: parameters, including clearance, volume of distribution, elimination T1/2, Cmax, and AUC will be determinate from analysis of collected blood samples | — |
Countries
Poland, United States
Contacts
Public ContactSr Director,Registration and Scient
Cumberland Pharmaceuticals Inc.
Outcome results
None listed