Clinical Trial: Creon After Pancreatic Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: One Week Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center Study With Creon® 25000 Minimicrospheres™ in Subjects With Pancreatic Exocrine Insu

Brief 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

Detailed Summary:
Sponsor: Abbott Products

Current Primary Outcome: Change in CFA from baseline to the end of double blind treatment [ Time Frame: 7 days after baseline ]

Original Primary Outcome: Change in CFA (coefficient of fat absorption) from baseline to the end of double blind treatment

Current Secondary Outcome: CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology, SF-36, BMI [ Time Frame: 7 days after baseline, and end of open-label period (1 year of open label treatment) ]

Original Secondary Outcome: CNA (coefficient of nitrogen absorption), stool fat, stool weight, nutritional laboratory parameters, clinical symptomatology, Quality of life (QqL) using GIQLI (Gastrointestinal Quality of Life Index), Body Mass Index (BMI)

Information By: Abbott

Dates:
Date Received: September 25, 2007
Date Started: April 2008
Date Completion:
Last Updated: August 16, 2011
Last Verified: August 2011