drugset / Trial / NCT00961753

Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates

NCT00961753 ↗

Phase 4 Terminated 10 enrolled OSF Healthcare System
RandomizedSingle-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.

Timeline

Start
2009-08
Primary completion
2010-10
Completion
2010-10

Outcome

Outcome not reported

Stopped: “FDA drug recall on July 30, 2010”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibuprofen Small molecule 5 mg/kg —
Subject Ibuprofen Small molecule 10 mg/kg —