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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cystic Fibrosis, Pancreatic Exocrine Insufficiency

In brief

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.

Key facts

Study ID

NCT00690820

Run by

Solvay Pharmaceuticals

People needed

17

Starts

2008-06-01

Expected to finish

2008-12-01

Last updated by the study team

2010-06-02

Who can join

Age: 7 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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 2 — Iowa City, Iowa, United States
• Site 5 — Louisville, Kentucky, United States
• Site 9 — Boston, Massachusetts, United States
• Site 6 — Ann Arbor, Michigan, United States
• Site 4 — Minneapolis, Minnesota, 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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