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

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 Chronic Pancreatitis, Followed by an Open-Label Long-Term Extension

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.

Inclusion Criteria

• Pancreatic exocrine insufficiency has to be proven (in medical history) by a pancreatic function test
• Chronic pancreatitis has to be proven (in medical history) by CT, ERCP, plain film with pancreatic calcifications, ultrasonography (calcifications,duct dilatation) and /or histology
• Females must be non-lactating and either be of non-childbearing potential or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1 (Day -14).
• Subjects with a pathological stool fat during run in period (> 10g/24 h)

Exclusion Criteria

• Ileus or acute abdomen
• Any type of malignancy involving the digestive tract in the last 5 years
• Presence of pseudo pancreatic cysts >= 4 cm
• Current excessive intake of alcohol or drug abuse
• Hypersensitivity vs porcine proteins / pancreatin