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NCT07225634
A Study of Combogesic® IV (Intravenous) in Pediatric Patients With Acute Pain
Conditions: Acute Pain
Sex: All
Ages: 2 Years – 16 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 60
Sponsor: AFT Pharmaceuticals, Ltd.
Location: Nemours Children's Health Orlando Florida
Summary
Combogesic® IV is an intravenous medicine (given by vein) containing a combination of two pain relief (analgesic) medicines called ibuprofen and acetaminophen. The goal of this clinical trial is to study the way that the body processes and clears the intravenous infusion of Combogesic® IV and that it is safe to be used in children and adolescents between the ages of 2 and \
Eligibility Criteria
Inclusion Criteria:
1. Is male or female aged between 2 and \ 2 weeks) of NSAIDs, opiates, or glucocorticoids (except inhaled nasal steroids and regional/limited topical corticosteroids), for any condition within 6 months before study drug administration. Aspirin at a daily dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the subject has been on a stable dose regimen for ≥ 30 days before screening and has not experienced any relevant medical problem.
12. Has a significant renal or hepatic disease, as indicated by clinical laboratory assessment (results ≥ 3 times the upper limit of normal \[ULN\] for any liver function test, including aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], or creatinine ≥ 1.5 times the ULN).
13. Has any clinically significant laboratory finding at screening that, in the opinion of the Investigator, contraindicates study participation.
14. Participated in another clinical study within 30 days before Screening.
15. Pregnant or lactating females
16. Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception
Source: ClinicalTrials.gov (NCT07225634). StuddyBuddy aggregates publicly available trial information.