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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.

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

Details

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

Criteria

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