Overview

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