At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 17 enrolled
Drug / intervention
Pancrelipase Delayed Release +1 moredrug
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.
A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
In Brief
A Phase 3 clinical trial evaluating Pancrelipase Delayed Release and Placebo Comparator for Cystic Fibrosis and Pancreatic Exocrine Insufficiency. Completed, enrolled 17 participants across 10 sites.
Detailed Summary
This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis, Pancreatic Exocrine Insufficiency
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJun 2008
Primary CompletionDec 2008
TodayJul 2026
First PostedJun 5, 2008
Enrollment StartJun 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.1 years ago
Interventions
Pancrelipase Delayed Releasedrug
12,000 unit Capsules, dosed individually based on fat intake.
Placebo Comparatordrug
Placebo