At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 52 enrolled
Drug / intervention
Pancrelipase delayed release capsule +1 moredrug
Likely dose
Pancrelipase delayed release capsule 24,000 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 Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
In Brief
A Phase 3 clinical trial evaluating Pancrelipase delayed release capsule and Placebo Comparator for Chronic Pancreatitis and 2 related conditions. Completed, enrolled 52 participants across 30 sites in 8 countries.
Detailed Summary
This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Poland, Puerto Rico, Russia, Serbia, South Africa, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2006
Enrollment StartOct 2007
Primary CompletionAug 2008
Study CompletionDec 2009
TodayJul 2026
First PostedDec 22, 2006
Enrollment StartOct 1, 2007
Primary CompletionAug 1, 2008
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.5 years ago
Interventions
Pancrelipase delayed release capsuledrug
24,000 unit capsule
Placebo Comparatordrug
Placebo