Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
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| ClinicalTrials.gov Identifier: NCT01002573 |
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Recruitment Status :
Completed
First Posted : October 27, 2009
Results First Posted : November 6, 2016
Last Update Posted : November 6, 2016
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Sponsor:
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
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Brief Summary:
The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fever | Drug: ibuprofen Drug: acetaminophen | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 118 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients |
| Study Start Date : | July 2010 |
| Actual Primary Completion Date : | June 2013 |
| Actual Study Completion Date : | June 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: ibuprofen
Ibuprofen, 10 mg/kg
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Drug: ibuprofen
Ibuprofen, 10 mg/kg |
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Active Comparator: Acetaminophen
Acetaminophen, 10mg/kg
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Drug: acetaminophen
Acetaminophen, 10mg/kg
Other Names:
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Primary Outcome Measures :
- Fever Reduction [ Time Frame: 0 to 2 hours post-dose ]Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)
Secondary Outcome Measures :
- Change From Baseline in Temperature After the First 30 Minutes of Treatment [ Time Frame: 30 minutes following treatment ]Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment.
- Change From Baseline in Temperature After the First 60 Minutes of Treatment [ Time Frame: 60 minutes following treatment ]Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment.
- Change in Temperature [ Time Frame: 4 hours following treatment ]Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment.
- Change From Baseline in Temperature After the First Four Hours of Treatment [ Time Frame: 0 to 4 hours post-dose ]Change in temperature during the first 4 hours of treatment by assessing the area under the change in temperature versus time curve during the first four hours of treatment (AUC0-4)
- Time to Afebrility (in Hours) [ Time Frame: 4 Hour post treatment ]Tme to afebrility (temperature less than 100.4 ºF [38 ºC]) in patients receiving intravenous ibuprofen and APAP.
- Number of Afebrile and Febrile Subject at 4 Hours Post-Dose [ Time Frame: 4 Hours Post-Dose ]Number of Afebrile and Febrile Subject at 4 Hours Following Treatment
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| Ages Eligible for Study: | up to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
- Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age.
- Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0 ºF (38.3 ºC).
Exclusion Criteria:
- Have inadequate intravenous access.
- Have received antipyretic drug therapy within 2 hours before dosing.
- Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
- Have received another investigational drug within the past 30 days.
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
- Have a fever due to hyperthermia.
- Pregnant or nursing.
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): NCT01002573
Locations
Show 17 study locations
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
| Study Director: | Art Wheeler, M.D. | Cumberland Pharmaceuticals, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cumberland Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01002573 |
| Other Study ID Numbers: |
CPI-CL-012 |
| First Posted: | October 27, 2009 Key Record Dates |
| Results First Posted: | November 6, 2016 |
| Last Update Posted: | November 6, 2016 |
| Last Verified: | September 2016 |
Keywords provided by Cumberland Pharmaceuticals:
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Pediatric Fever |
Additional relevant MeSH terms:
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Fever Body Temperature Changes Acetaminophen Ibuprofen Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Antipyretics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |