Status:
COMPLETED
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Cystic Fibrosis
Pancreatic Exocrine Insufficiency
Eligibility:
All Genders
1-6 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
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 :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00775528
Start Date
April 1 2009
End Date
June 1 2009
Last Update
November 8 2010
Active Locations (12)
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1
Site 11
Boise, Idaho, United States
2
Site 5
Louisville, Kentucky, United States
3
Site 9
Boston, Massachusetts, United States
4
Site 6
Ann Arbor, Michigan, United States