drugset / Trial / NCT00846963

Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

NCT00846963

Phase 2/3 Completed 26 enrolled Ibrahim Mohamed
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether ursodiol is effective in the treatment of parenteral nutrition associated cholestasis in neonates.

Timeline

Start
2008-10
Primary completion
2012-12
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ursodeoxycholic Acid Small molecule 3.3 mg/kg Oral
Subject Ursodeoxycholic Acid Small molecule 6.7 mg/kg Oral
Subject Ursodeoxycholic Acid Small molecule 10 mg/kg Oral

Indications