Status:
COMPLETED
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Cystic Fibrosis
Pancreatic Exocrine Insufficiency
Eligibility:
All Genders
7-11 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00690820
Start Date
June 1 2008
End Date
December 1 2008
Last Update
June 2 2010
Active Locations (10)
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1
Site 2
Iowa City, Iowa, United States
2
Site 5
Louisville, Kentucky, United States
3
Site 9
Boston, Massachusetts, United States
4
Site 6
Ann Arbor, Michigan, United States