Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
NCT ID: NCT00775528
Last Updated: 2010-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
19 participants
INTERVENTIONAL
2009-04-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Pancrelipase Delayed Release
3,000, 6,000 and 12,000 unit Lipase Capsules
Interventions
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Pancrelipase Delayed Release
3,000, 6,000 and 12,000 unit Lipase Capsules
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
1 Month
6 Years
ALL
No
Sponsors
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Solvay Pharmaceuticals
INDUSTRY
Responsible Party
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Solvay Pharmaceuticals
Principal Investigators
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Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
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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
Countries
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References
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Graff GR, McNamara J, Royall J, Caras S, Forssmann K. Safety and tolerability of a new formulation of pancrelipase delayed-release capsules (CREON) in children under seven years of age with exocrine pancreatic insufficiency due to cystic fibrosis: an open-label, multicentre, single-treatment-arm study. Clin Drug Investig. 2010;30(6):351-64. doi: 10.2165/11533390-000000000-00000.
Other Identifiers
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S245.3.128
Identifier Type: -
Identifier Source: org_study_id