Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Inclusion Criteria: * Confirmed Cystic Fibrosis (CF) diagnosis by two positive chloride sweat tests or gene analysis * Current or historical human fecal elastase \< 50µg/gstool * Weight greater than 3.75 kg * Age 1 month to 6 years * Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months * Clinically stable condition without evidence of acute respiratory disease or any other acute condition Exclusion Criteria: * Ileus or acute abdomen * History of fibrosing colonopathy, Celiac disease, gastrectomy, Crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome * History of distal ileal obstruction syndrome within 6 months of enrollment * Use of an immunosuppressive drug * Any type of malignancy involving the digestive tract in the last 5 years * Known infection with HIV