A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients
| City: |
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Tulsa |
| State: |
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Oklahoma |
| Zip Code: |
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74136 |
| Conditions: |
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Fever |
| Purpose: |
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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.
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| Study Summary: |
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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 as measured by
the area under the change in temperature versus time curve during the first 2 hours of
treatment.
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| Criteria: |
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Inclusion Criteria:
1. Have written informed consent provided by legal parent, guardian, or authorized agent
prior to participation in the study or study-only related procedures.
2. Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age.
3. Have new (less than 7 days) onset of fever, documented by temperature greater than or
equal to 101.0ºF (38.3ºC).
Exclusion Criteria:
1. Have inadequate intravenous access.
2. Have received antipyretic drug therapy within 2 hours before dosing.
3. Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
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. Have a fever due to hyperthermia.
7. Pregnant or nursing.
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| NCT ID: |
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NCT01002573 |
| Primary Contact: |
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Study Director
Art Wheeler, M.D.
Cumberland Pharmaceuticals Inc
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| Backup Contact: |
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N/A |
| Location Contact: |
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Tulsa, Oklahoma 74136
United States
Kellie Brown, RN
Phone: 918-502-6136
Email: kebrown@saintfrancis.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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