Clinical Trial: Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis

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

Official Title: A One Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study With Creon 40,000 MMS in Subjects With Pancreatic Exocrine Insufficiency Due to

Brief Summary: This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 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: Same as current

Current Secondary Outcome: CNA, stool fat, stool weight, nutritional, 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: Same as current

Information By: Abbott

Dates:
Date Received: June 26, 2008
Date Started: June 2008
Date Completion:
Last Updated: August 16, 2011
Last Verified: August 2011