Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency

The primary objective of this clinical trial is to demonstrate non-inferiority clinical development of pancreatic enzymes from Laboratory Bergamo (Norzyme ®) in relation to pancreatic enzymes from Solvay Pharmaceuticals (Creon ®), by comparing the average amount of lipids in the feces of 72 hours after 14 days of treatment with each drug.

As a secondary objective will be assessed the following parameters:

• Incidence of abdominal pain;
• Frequency of flatus;
• Frequency of bowel movements during the treatment;
• Consistency of stools during treatment;
• Amount of medication used among the treatments. All these parameters will be measured based on reports of patients in a specific diary.

Inclusion Criteria:

• Patients must agree with the purposes of the study and sign the Informed Consent in two ways;
• Be aged over 18 years;
• Display chronic exocrine pancreatic insufficiency due to chronic pancreatic, post surgical or other situation that leads to severe glandular disease;
• Doing controlled clinical treatment of enzyme replacement with Creon ® 25,000 (or similar with the same concentration of lipase) during meals;
• Agree to record daily food intake in phase 2 and repeat the diet in phase 3;
• Present ability to meet the patient's diary;
• Be clinically compensated with replacement therapy;
• Must be admitted patients in both the sexes;
• Must be accepted patients of any ethnicity.

Exclusion Criteria:

• Cystic fibrosis;
• Acute pancreatitis;
• Participation in any experimental study or ingestion of any experimental drug in the 12 months preceding the study;
• Diabetes decompensated;
• Regular use of medications that interfere with the action of the drug test: the 4 weeks preceding the study or any medication that interferes with the drug test a week before the start of the study;
• Any type of treatment for morbid obesity;
• Abusive use of alcohol in the three months preceding the study;
• Pregnancy and lactation.