Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)
NCT ID: NCT00690820
Last Updated: 2010-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
17 participants
INTERVENTIONAL
2008-06-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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A
Pancrelipase Delayed Release
12,000 unit Capsules, dosed individually based on fat intake.
B
Placebo Comparator
Placebo
Interventions
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Pancrelipase Delayed Release
12,000 unit Capsules, dosed individually based on fat intake.
Placebo Comparator
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
7 Years
11 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 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
Countries
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References
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Graff GR, Maguiness K, McNamara J, Morton R, Boyd D, Beckmann K, Bennett D. Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study. Clin Ther. 2010 Jan;32(1):89-103. doi: 10.1016/j.clinthera.2010.01.012.
Caras S, Boyd D, Zipfel L, Sander-Struckmeier S. Evaluation of stool collections to measure efficacy of PERT in subjects with exocrine pancreatic insufficiency. J Pediatr Gastroenterol Nutr. 2011 Dec;53(6):634-40. doi: 10.1097/MPG.0b013e3182281c38.
Other Identifiers
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S245.3.127
Identifier Type: -
Identifier Source: org_study_id
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