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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Pancreatin; Pancrelipase

Criteria

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