NCT00535756

Creon After Pancreatic Surgery

One Week Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center Study With Creon® 25000 Minimicrospheres™ in Subjects With Pancreatic Exocrine Insufficiency After Pancreatic Surgery, Followed by an Open-Label Long-Term Extension of 1 Year

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Abbott Products · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with CFA

Conditions

• Pancreatic Insufficiency

Interventions

Type	Name	Description
DRUG	Creon	3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)
DRUG	Placebo	Placebo

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2007-09-26
• Last updated: 2011-08-18

Locations

15 sites across 4 countries: Bulgaria, Germany, Hungary, Italy