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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00510484

Run by

Solvay Pharmaceuticals

People needed

35

Starts

2007-11-01

Expected to finish

2008-03-01

Last updated by the study team

2010-06-03

Who can join

Age: 12 and older. 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 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

You may not qualify if…

• 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

Where it is running

• Site 11 — Long Beach, California, United States
• Site 10 — Los Angeles, California, United States
• Site 13 — San Francisco, California, United States
• Site 5 — Miami, Florida, United States
• Site 4 — Orlando, Florida, United States
• Site 1 — Iowa City, Iowa, United States
• Site 7 — Louisville, Kentucky, United States
• Site 17 — Boston, Massachusetts, United States
• Site 8 — Ann Arbor, Michigan, United States
• Site 6 — Minneapolis, Minnesota, United States
• Site 18 — Long Branch, New Jersey, United States
• Site 16 — Albuquerque, New Mexico, United States
• Site 19 — Cincinnati, Ohio, United States
• Site 12 — Dayton, Ohio, United States
• Site 2 — Toledo, Ohio, United States
• Site 14 — Oklahoma City, Oklahoma, United States
• Site 3 — Hershey, Pennsylvania, United States
• Site 15 — Philadelphia, Pennsylvania, United States
• Site 9 — Nashville, Tennessee, United States
• Site 20 — Petrofi, Hungary
• Site 21 — Jerusalem, Israel
• Site 22 — Johannesburg, South Africa
• Site 23 — Barcelona, Spain

Full record on ClinicalTrials.gov

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