At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 19 enrolled
Drug / intervention
Pancrelipase Delayed Releasedrug
Likely dose
Pancrelipase Delayed Release 12,000 unitfrom 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, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
In Brief
A Phase 3 clinical trial evaluating Pancrelipase Delayed Release for Cystic Fibrosis and Pancreatic Exocrine Insufficiency. Completed, enrolled 19 participants across 12 sites.
Detailed Summary
This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis, Pancreatic Exocrine Insufficiency
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartApr 2009
Primary CompletionJun 2009
TodayJul 2026
First PostedOct 20, 2008
Enrollment StartApr 1, 2009
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.7 years ago
Interventions
Pancrelipase Delayed Releasedrug
3,000, 6,000 and 12,000 unit Lipase Capsules