At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 35 enrolled
Drug / intervention
Pancrelipase Delayed Release +1 moredrug
Likely dose
Pancrelipase Delayed Release 24000 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 24,000 Unit Capsules in Subjects 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. Completed, enrolled 35 participants across 23 sites in 5 countries.
Detailed Summary
This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesHungary, Israel, South Africa, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2007
Enrollment StartNov 2007
Primary CompletionMar 2008
TodayJul 2026
First PostedAug 2, 2007
Enrollment StartNov 1, 2007
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.9 years ago
Interventions
Pancrelipase Delayed Releasedrug
24000 unit Capsule
Placebo Comparatordrug
Placebo