At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 40 enrolled
Drug / intervention
Pancreatindrug
Likely dose
Not stated in 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.
An Open Label, Multicenter Study Evaluating Safety and Tolerability of Creon Micro in Pediatric Subjects From at Least One Month to Less Than Four Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
In Brief
A Phase 3 clinical trial evaluating Pancreatin for Pancreatic Exocrine Insufficiency. Completed, enrolled 40 participants across 9 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Exocrine Insufficiency
CountriesRussia
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2012
Primary CompletionDec 2012
First PostedDec 2012
TodayJul 2026
First PostedDec 11, 2012
Enrollment StartJun 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.6 years ago
Interventions
Pancreatindrug
Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used