CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 26 enrolled
Drug / intervention
Ursodiol +1 moredrug
Likely dose
Ursodiol 3,3mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00846963
NCT00846963Phase 3Completed
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Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

Ibrahim Mohamed·interventional·Posted Feb 19, 2009·Updated Sep 17, 2013

In Brief

A Phase 3 clinical trial evaluating Ursodiol and placebo for Cholestasis. Completed, enrolled 26 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholestasis
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2009
Enrollment StartOct 1, 2008
Primary CompletionDec 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 17.4 years ago

Interventions

Ursodioldrug

Ursodiol is given by mouth, three times a day from second value of elevated conjugated bilirubin (\>33mmol/L) to the resolution of cholestasis (conjugated bilirubin \<34mmol/L) If Nil per os, 3,3mg/kg/dose is given. If Nil per os is required (e.g. pre-surgery, or necrotizing enterocolitis), none is given. If enteral feeding is under 100mL/kg/day, 6,7 mg/kg/day is given. If enteral feeding exceeds 100mL/kg/day, 10 mg/kg/day is given.

placebodrug

Placebo given in the same amount that ursodiol would be given, depending on enteral feeding and weight. It is also given three times a day, until cholestasis resolution.