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

Completed · Phase 3

Conditions studied: Cystic Fibrosis, Pancreatic Exocrine Insufficiency

In brief

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.

Key facts

Study ID

NCT00775528

Run by

Solvay Pharmaceuticals

People needed

19

Starts

2009-04-01

Expected to finish

2009-06-01

Last updated by the study team

2010-11-08

Who can join

Age: 0 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site 11 — Boise, Idaho, United States
• Site 5 — Louisville, Kentucky, United States
• Site 9 — Boston, Massachusetts, United States
• Site 6 — Ann Arbor, Michigan, United States
• Site 12 — Detroit, Michigan, United States
• Site 4 — Minneapolis, Minnesota, United States
• Site 13 — Long Branch, New Jersey, United States
• Site 8 — Albuquerque, New Mexico, United States
• Site 1 — Cincinnati, Ohio, United States
• Site 10 — Oklahoma City, Oklahoma, United States
• Site 7 — Oklahoma City, Oklahoma, United States
• Site 3 — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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