Overview
Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Status:
Completed
Completed
Trial end date:
2008-03-01
2008-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Solvay PharmaceuticalsTreatments:
Pancreatin
Pancrelipase
Criteria
Inclusion Criteria:- Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
- Confirmed PEI by historical CFA < 70% without supplementation or current or historical
fecal elastase < 50µg/g stool (within the last 12 months)
- Subjects of 12 years or older
- 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
- Females of child-bearing potential must agree to continue using a medically acceptable
method of birth control
Exclusion Criteria:
- Ileus or acute abdomen
- History of fibrosing colonopathy
- 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