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

A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.

Inclusion Criteria:

• Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
• Confirmed PEI by historical Coefficient of fat Absorption < 70% without supplementation or current or historical fecal elastase < 50µg/stool (within the last 12 months)
• 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
• Stable body weight and agrees to abstain from sexual activity

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